Pharmaceutical Engineering Home | ISPE | International Society for Pharmaceutical Engineering

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class="has-lead-form node node--type-magazine-article node--view-mode-featured-on-landing-page"> <div class="view-mode-featured_on_landing_page"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/november-december-2024/plastic-process-waste-biopharmaceutical"> <img loading="eager" srcset="/sites/default/files/styles/max_325x325/public/2024-11/1124_PE_ND_Cover_01.jpg?itok=UpT_bnss 325w, /sites/default/files/styles/max_650x650/public/2024-11/1124_PE_ND_Cover_01.jpg?itok=cfzAzRwc 650w, /sites/default/files/styles/max_1300x1300/public/2024-11/1124_PE_ND_Cover_01.jpg?itok=IjcMDyFf 1300w, /sites/default/files/styles/max_2600x2600/public/2024-11/1124_PE_ND_Cover_01.jpg?itok=axFAYMl4 1900w" sizes="(min-width: 1290px) 1290px, 100vw" src="/sites/default/files/styles/max_1300x1300/public/2024-11/1124_PE_ND_Cover_01.jpg?itok=IjcMDyFf" width="1300" height="411" alt="Plastic Process Waste in Biopharmaceutical Manufacturing" /> </a> </div> <div class="content-overlay"> <div class="node-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/november-december-2024/plastic-process-waste-biopharmaceutical" hreflang="en">Plastic Process Waste in Biopharmaceutical Manufacturing</a></div> </div> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Features</div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-01T15:35:00Z">1 November 2024</time> </div> – <div class="tex2jax_process"><p>This article presents a comprehensive analysis of plastic waste generation in the biopharmaceutical industry, focusing on using single-use technologies (SUT) in bioprocessing for monoclonal antibody (mAb) production. It aims to inform sustainable practices within the biopharmaceutical industry and to encourage the development of more sustainable disposable technologies.</p></div> </div> </div> </article> </div> </div> </div> </section> <section class="views-element-container block-style-bold m-t-3 block-views-block-articles-block-2 block block-views block-views-blockarticles-block-2" id="block-views-block-articles-block-2"> <h2 class="block-title">Featured Articles</h2> <div><div class="view--id-articles js-view-dom-id-7c36db9634f520f493c49585a8320400eb1bc2bbd62707b063ef8ba5e52e4e28"> <div class="views-row"> <article id="node-279454" data-history-node-id="279454" class="has-lead-form magazine-article-card pemag-teaser"> <div> <div class="row"> <div class="medium-6 columns"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/november-december-2024/3r-initiative-within-roches-global-qc-network" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/1124_PE_ND_Deuts_01.jpg?itok=9W8y3jT4" width="1000" height="600" alt="3R Initiative Within Roche’s Global QC Network" /> </a> </div> </div> <div class="medium-6 columns"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Features</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/november-december-2024/3r-initiative-within-roches-global-qc-network" hreflang="en">3R Initiative Within Roche’s Global QC Network</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-01T14:15:00Z">1 November 2024</time> </div> <div class="tex2jax_process"><p>This article describes the numerous activities in the commercial quality control (QC) network that aim to replace in vivo assays with alternative methods in the course of production and release.<span class="footnote__citations-wrapper"><a class="footnote__citation js-footnote-citation" id="footnoteref1_zZybUM9Aoua66MmiY1dLEyXVQHR2M2h9hT4qSNW90I_hzM04djYCdMc" title="Russell, W., and R. L. Burch. The Principles of Humane Experimental Technique, Special Edition. London, UK: Methuen & Co Ltd. Published by Universities Federation..." href="#footnote1_zZybUM9Aoua66MmiY1dLEyXVQHR2M2h9hT4qSNW90I_hzM04djYCdMc">1</a></span></p></div> </div> </div> </div> </article> </div> </div> </div> </section> <section class="views-element-container block-views-block-articles-block-3 block block-views block-views-blockarticles-block-3" id="block-views-block-articles-block-3"> <div><div class="row load-every-three view--id-articles js-view-dom-id-3dfcdb160a8762ce5a7a7e98a62c7d2f13eaf74875926e33ca7110b238d4b44b"> <div class="small-12 medium-4 columns views-row"> <article id="node-279466" data-history-node-id="279466" class="has-lead-form magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/november-december-2024/decarbonizing-pharmaceutical-manufacturing" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/1124_PE_ND_Goto_01.jpg?itok=0-QK-lxb" width="1000" height="600" alt="Decarbonizing Pharmaceutical Manufacturing Facilities" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Features</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/november-december-2024/decarbonizing-pharmaceutical-manufacturing" hreflang="en">Decarbonizing Pharmaceutical Manufacturing Facilities</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-01T14:08:00Z">1 November 2024</time> </div> <div class="tex2jax_process"><p>Reducing the pharmaceutical industry’s carbon footprint has become a management responsibility. This article introduces some of the key points, actual methods, and practical examples of our implementation to reduce carbon emissions from pharmaceutical manufacturing facilities in Southeast Asia.</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279567" data-history-node-id="279567" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/november-december-2024/net-zero-manufacturing-facilities-obstacles-and" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/1124_pe_nd_deuts_01_0.jpg?itok=JE-yH2tR" width="1000" height="600" alt="Net-Zero Manufacturing Facilities: Obstacles and Benefits" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Technical</div> <div class="magazine-title is-premium"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/november-december-2024/net-zero-manufacturing-facilities-obstacles-and" hreflang="en">Net-Zero Manufacturing Facilities: Obstacles and Benefits</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-01T13:42:00Z">1 November 2024</time> </div> <div class="tex2jax_process"><p>The decision to pursue net-zero facility design in manufacturing is complicated. There are significant challenges related to initial project costs, physical space constraints, and project site considerations—but also substantive benefits from operational savings, environmental impact, building brand trust, and working toward a more sustainable future.</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279506" data-history-node-id="279506" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/november-december-2024/single-use-technology-waste-manufacturing" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/1124_PE_ND_P%2BE_01.jpg?itok=9ylCZvz6" width="1000" height="600" alt="Single-Use Technology Waste in Manufacturing Operations" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Technical</div> <div class="magazine-title is-premium"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/november-december-2024/single-use-technology-waste-manufacturing" hreflang="en">Single-Use Technology Waste in Manufacturing Operations</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-01T13:32:13Z">1 November 2024</time> </div> <div class="tex2jax_process"><p>Single-use products used in the production of biologics provide flexibility that was unimaginable a few years ago. The implementation of single-use technology (SUT) in manufacturing operations has accelerated due to reduced risk, flexible process equipment adjustments, and lower capital cost. The widespread use of this technology has raised questions about its impact on the environment due to...</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279492" data-history-node-id="279492" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/november-december-2024/cloud-service-provider-exit-strategy" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/1124_pe_nd_deuts_01.jpg?itok=xEid9fBK" width="1000" height="600" alt="A Cloud Service Provider Exit Strategy" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Technical</div> <div class="magazine-title is-premium"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/november-december-2024/cloud-service-provider-exit-strategy" hreflang="en">A Cloud Service Provider Exit Strategy</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-01T13:30:14Z">1 November 2024</time> </div> <div class="tex2jax_process"><p>Traditionally, a regulated company is accountable for all aspects of their infrastructure qualification and application validation. With the introduction of public cloud service providers (CSPs), part of that technical responsibility has shifted to a cloud supplier, making supplier assessment and supplier management more important than ever—even though the regulated company is still...</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279562" data-history-node-id="279562" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/november-december-2024/volunteer-profile-combination-products-community" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/CoP-James%20P.%20Wabby.jpg?itok=6ZUzW2sE" width="1000" height="600" alt="Volunteer Profile: Combination Products Community of Practice Chair - James P. Wabby, MHMS" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">InTouch</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/november-december-2024/volunteer-profile-combination-products-community" hreflang="en">Volunteer Profile: Combination Products Community of Practice Chair - James P. Wabby, MHMS</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-01T12:26:00Z">1 November 2024</time> </div> <div class="tex2jax_process"><p>For more than 22 years, James P. Wabby has dedicated his career to quality operations, regulatory compliance, and regulatory affairs pertaining to medical device technology, medicinal delivery platforms, complex generics, companion diagnostics, digital medicine, and combination product areas. In 2017, during one of the biggest regulatory changes within the European Union in over 20 years,...</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279561" data-history-node-id="279561" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/november-december-2024/volunteer-profile-sustainability-community" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/CoP-ESTER%20LOVSIN%20BARLE_0.jpg?itok=tCHDrrlb" width="1000" height="600" alt="Ester Lovsin Barle, DVM, MSC, PHD, MSCTOX" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">InTouch</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/november-december-2024/volunteer-profile-sustainability-community" hreflang="en">Volunteer Profile: Sustainability Community of Practice Chair - Ester Lovsin Barle, DVM, MSC, PHD, MSCTOX</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-01T12:25:00Z">1 November 2024</time> </div> <div class="tex2jax_process"><p>Ester Lovsin Barle’s journey from veterinary lecturer in Slovenia to the Global Head of Product Sustainability and Stewardship at Takeda Pharmaceuticals in Switzerland was fueled by her curiosity and passion for continual learning and a desire to help others do the same. “We are never at the end of our learning curve, and it’s so important to continue to learn and be open-minded about new...</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279557" data-history-node-id="279557" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/november-december-2024/foya-projects-embrace-innovative-sustainability" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/24%20FOYA%20-%20General%20Website%20Hero%20Graphic.jpg?itok=CouR4guU" width="1000" height="600" alt="24 FOYA - General Website Hero" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">InTouch</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/november-december-2024/foya-projects-embrace-innovative-sustainability" hreflang="en">FOYA Projects Embrace Innovative Sustainability Solutions</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-01T12:15:00Z">1 November 2024</time> </div> <div class="tex2jax_process"><p>Established in 2004, the Facility of the Year Awards (FOYA) recognize state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery.</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279563" data-history-node-id="279563" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/november-december-2024/ispe-releases-new-gampr-good-practice-guide" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/Validation%20and%20Compliance%20of%20Computerized%20GCP%20Systems%20and%20Data-thumbnail.jpg?itok=IVnX2AIt" width="1000" height="600" alt="ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice (Second Edition)" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">InTouch</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/november-december-2024/ispe-releases-new-gampr-good-practice-guide" hreflang="en">ISPE Releases New GAMP® Good Practice Guide</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-01T12:12:00Z">1 November 2024</time> </div> <div class="tex2jax_process"><p>This summer ISPE released the <a href="/publications/guidance-documents/gamp-good-practice-guide-computerized-gcp-systems-data-2nd-edition" title="GAMP Good Practice Guide: Computerized GCP Systems & Data 2nd Edition" data-entity-type="node" data-entity-uuid="50093e88-cb0e-4a4f-9fe2-09eb1cffad4a" data-entity-substitution="canonical">ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice (Second...</a></p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279558" data-history-node-id="279558" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/november-december-2024/be-inspired-ispe-pharma-40tm-and-annex-1" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/24%20Pharma%20Web%20Assets%20_No_Cta_1200_627.jpg?itok=rD50Bvvq" width="1000" height="600" alt="2024 ISPE Pharma 4.0™ and Annex 1 Conference" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">InTouch</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/november-december-2024/be-inspired-ispe-pharma-40tm-and-annex-1" hreflang="en">Be Inspired at the ISPE Pharma 4.0™ and Annex 1 Conference</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-01T12:10:00Z">1 November 2024</time> </div> <div class="tex2jax_process"><p>The <a href="/node/263581" title="2024 ISPE Pharma 4.0™ and Annex 1 Conference" data-entity-type="node" data-entity-uuid="6b7f4309-c288-4bba-9aeb-73c7768503cd" data-entity-substitution="canonical">2024 ISPE Pharma 4.0™ and Annex 1 Conference</a> will be held 10–11 December in Rome, Italy, and virtually. Richard Denk and Line Lundsberg-Nielsen, the conference’s Executive Chairs, offer advice...</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-275913" data-history-node-id="275913" class="has-lead-form magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/september-october-2024/industry-perspectives-practical-application" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-09/0924_PE_SO_Graul_01.jpg?itok=yuamhyKW" width="1000" height="600" alt="Industry Perspectives on Practical Application of Platform Analytical Procedures" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Features</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/september-october-2024/industry-perspectives-practical-application" hreflang="en">Industry Perspectives on Practical Application of Platform Analytical Procedures</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-09-01T14:51:00Z">1 September 2024</time> </div> <div class="tex2jax_process"><p>Pharmaceutical and biotechnology companies employ platform analytical procedures in the development stages of their synthetic and biological drug products and are beginning to leverage them for commercial products. This shift is supported by the acceptance of platform procedures in the recently adopted ICH Q2(R2) and ICH Q14. Six case studies are shared in this article to highlight how...</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-275856" data-history-node-id="275856" class="has-lead-form magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/september-october-2024/global-collaborative-review-understanding-overall" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-09/0924_PE_SO_Ab_01.jpg?itok=1V3YmOiQ" width="1000" height="600" alt="Global Collaborative Review: Understanding Overall Control Strategy and Patient Benefit-Risk" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Features</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/september-october-2024/global-collaborative-review-understanding-overall" hreflang="en">Global Collaborative Review: Understanding Overall Control Strategy and Patient Benefit-Risk</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-09-01T14:50:00Z">1 September 2024</time> </div> <div class="tex2jax_process"><p>The pharmaceutical industry faces considerable challenges throughout the development, manufacturing, and supply of medicines, largely due to the intricate and divergent global regulatory landscape. The adoption of structured data standards and utilization of cloud-based platforms offer immense potential to overcome these challenges by facilitating faster and more efficient global...</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-275162" data-history-node-id="275162" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/september-october-2024/2024-ispe-aseptic-regulatory-panel-qa" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-08/2024%20ISPE%20Aseptic%20Regulatory%20Panel%20Q%26A-exclusive.jpg?itok=eVhZHbge" width="1000" height="600" alt="2024 ISPE Aseptic Regulatory Panel Q&A" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Online Exclusives</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/september-october-2024/2024-ispe-aseptic-regulatory-panel-qa" hreflang="en">2024 ISPE Aseptic Regulatory Panel Q&A</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-08-08T14:16:55Z">8 August 2024</time> </div> <div class="tex2jax_process"><p>On 13 March 2024, ISPE concluded the 2024 Aseptic Conference with a regulatory panel question and answer session. Attendees were invited to submit questions to representatives from the Austrian Agency for Health and Food Safety (AGES), US Food and Drug Administration (FDA), Regierungspraesidium Tübingen (RP Tübingen), World Health Organization (WHO), Therapeutic Goods Administration (TGA), and...</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-274009" data-history-node-id="274009" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/july-august-2024/pharma-facilities-composable-tools-and-validation-40" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-07/0724_PE_JA_Vuolo_01.jpg?itok=GBxjQNZG" width="1000" height="600" alt="0724_PE_JA_Vuolo_01.jpg (212.7 KB) " /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Features</div> <div class="magazine-title is-premium"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/july-august-2024/pharma-facilities-composable-tools-and-validation-40" hreflang="en">Pharma Facilities, Composable Tools, and Validation 4.0</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-07-01T15:00:08Z">1 July 2024</time> </div> <div class="tex2jax_process"><p>The pharmaceutical industry stands at the precipice of a revolution as emerging digital technologies provide new opportunities to boost productivity through continuous process improvements. The Pharma 4.0™ framework, an adaptation of the broader Industry 4.0 movement, aims to transform how drugs are produced and delivered.</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-274017" data-history-node-id="274017" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/july-august-2024/gene-editing-and-facility-retrofits-crispr-and-beyond" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-07/0724_PE_JA_Heff_01.jpg?itok=lvJSqvGs" width="1000" height="600" alt="Gene Editing and Facility Retrofits for CRISPR and Beyond" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Features</div> <div class="magazine-title is-premium"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/july-august-2024/gene-editing-and-facility-retrofits-crispr-and-beyond" hreflang="en">Gene Editing and Facility Retrofits for CRISPR and Beyond</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-07-01T14:58:17Z">1 July 2024</time> </div> <div class="tex2jax_process"><p>With the approval of the first gene edited therapeutic in 2023, production of gene edited therapies is accelerating, introducing tough decisions for manufacturing development. Gene editing therapy production is complex, often involving multi-modality manufacturing operations in one facility to produce a single therapeutic. This article considers whether retrofitting an aging monoclonal...</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-274068" data-history-node-id="274068" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/july-august-2024/automation-supports-esg-goals-pharma-facility" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-07/0724_PE_JA_Knapp_01.jpg?itok=-ZbCH4vE" width="1000" height="600" alt="Automation Supports ESG Goals for Pharma Facility Conversion" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Features</div> <div class="magazine-title is-premium"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/july-august-2024/automation-supports-esg-goals-pharma-facility" hreflang="en">Automation Supports ESG Goals for Pharma Facility Conversion</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-07-01T14:31:28Z">1 July 2024</time> </div> <div class="tex2jax_process"><p>Implementing advanced automation technologies is a strategic move that can amplify the positive outcomes of environmental, social, and governance (ESG) initiatives. By leveraging ESG initiatives, pharmaceutical companies can enhance their competitive edge and contribute positively to global sustainability efforts.</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-271449" data-history-node-id="271449" class="has-lead-form magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/may-june-2024/post-approval-change-management-cell-and-gene-therapy" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-04/0524_PE_MJ_Amaya_01.jpg?itok=eLKaIocr" width="1000" height="600" alt="Post-approval Change Management for Cell and Gene Therapy Products" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Features</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/may-june-2024/post-approval-change-management-cell-and-gene-therapy" hreflang="en">Post-Approval Change Management for Cell and Gene Therapy Products</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-05-01T13:20:14Z">1 May 2024</time> </div> <div class="tex2jax_process"><p>Cell and gene therapy (C&GT) products represent a significant step forward in patient treatment and often offer unique patient benefits. However, product developers face significant hurdles within the regulatory landscape. The tools laid out in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q12 guideline: “Technical and...</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-271453" data-history-node-id="271453" class="has-lead-form magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/may-june-2024/silico-data-driven-mechanistic-model-assisted-process" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-04/0524_PE_MJ_wheaton_01.jpg?itok=0cY8uAV0" width="1000" height="600" alt="In-Silico Data-Driven Mechanistic Model–Assisted Process Validation" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Features</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/may-june-2024/silico-data-driven-mechanistic-model-assisted-process" hreflang="en">In-Silico Data-Driven Mechanistic Model–Assisted Process Validation</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-05-01T13:19:13Z">1 May 2024</time> </div> <div class="tex2jax_process"><p>The US Food and Drug Administration (FDA) advocates for the integration of quality by design (QbD) principles throughout the pharmaceutical product development landscape, aiming to elevate both process understanding and product quality. Key challenges to the process control strategy include navigating time- and resource-intensive processes. One solution is digital shadow technology which, when...</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-271601" data-history-node-id="271601" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/may-june-2024/quality-risk-management-biopharmaceuticals" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-04/0524_PE_MJ_Keuhne_01.jpg?itok=5unrwA-K" width="1000" height="600" alt="Quality Risk Management for Biopharmaceuticals" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Features</div> <div class="magazine-title is-premium"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/may-june-2024/quality-risk-management-biopharmaceuticals" hreflang="en">Quality Risk Management for Biopharmaceuticals</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-05-01T13:15:00Z">1 May 2024</time> </div> <div class="tex2jax_process"><p>In the dynamic and highly regulated world of biopharmaceutical manufacturing, maintaining and ensuring quality is a critical success factor. An effective quality risk management (QRM) system is a key component in the overall quality management infrastructure of biopharmaceutical organizations. It offers a structured, scientific, and risk-based approach to decision-making, addressing potential...</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-271580" data-history-node-id="271580" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/may-june-2024/cell-culture-media-manufacturing-controls-bio" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-04/0524_PE_MJ_Paz_01.jpg?itok=ppXdDQ9s" width="1000" height="600" alt="Cell Culture Media Manufacturing Controls for Bio-Manufacturing" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Features</div> <div class="magazine-title is-premium"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/may-june-2024/cell-culture-media-manufacturing-controls-bio" hreflang="en">Cell Culture Media Manufacturing Controls for Bio-Manufacturing</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-05-01T13:12:00Z">1 May 2024</time> </div> <div class="tex2jax_process"><p>Advanced therapy medicinal products (ATMPs) and cell and gene therapies (C&GTs) represent a promising medical product class that employs gene therapy, cell therapy, or tissue engineering to address various diseases and injuries. One critical aspect of ATMP and C&GT manufacturing is using cell culture media. With thousands of ATMPs and C&GTs in clinical trial phases, the role of...</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-271578" data-history-node-id="271578" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/may-june-2024/building-better-therapies-antibody-engineering" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-04/0524_PE_MJ_Choudhari_01.jpg?itok=5GccjX4p" width="1000" height="600" alt="Building Better Therapies With Antibody Engineering" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Features</div> <div class="magazine-title is-premium"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/may-june-2024/building-better-therapies-antibody-engineering" hreflang="en">Building Better Therapies With Antibody Engineering</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-05-01T13:10:00Z">1 May 2024</time> </div> <div class="tex2jax_process"><p>Antibody engineering has transformed the development of therapeutic antibodies, enabling the creation of specific and effective treatments for a range of diseases. These antibody-based therapeutics are advancing in clinical development at a rapid rate and are being approved in record numbers. Currently, more than 100 monoclonal antibodies (mAbs) have been approved for the treatment of various...</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-271572" data-history-node-id="271572" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/may-june-2024/continuous-buffer-management-system-large-scale-buffer" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-04/0524_PE_MJ_Jin_01.jpg?itok=n99OC8Iw" width="1000" height="600" alt="Continuous Buffer Management System: Large-Scale Buffer Preparation" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Features</div> <div class="magazine-title is-premium"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/may-june-2024/continuous-buffer-management-system-large-scale-buffer" hreflang="en">Continuous Buffer Management System: Large-Scale Buffer Preparation</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-05-01T13:00:00Z">1 May 2024</time> </div> <div class="tex2jax_process"><p>Although traditional tank farm systems have long been the cornerstone of buffer preparation, they face challenges that have grown with the expansion of processing scale in the industry.<fn value="1" text="National Institute for Innovation in Manufacturing Biopharmaceuticals-BioPhorum. “Buffer Stock Blending System: A More Advanced Concept for Buffer Manufacturing.” BioPhorum. 29 November 2019...."></fn></p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-268493" data-history-node-id="268493" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/march-april-2024/evolving-chinas-regulatory-system-alignment-ich" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-03/0324_PE_MA_Zhang_01.jpg?itok=tNmJ1JkW" width="1000" height="600" alt="Evolving China’s Regulatory System in Alignment with ICH" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Features</div> <div class="magazine-title is-premium"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/march-april-2024/evolving-chinas-regulatory-system-alignment-ich" hreflang="en">Evolving China’s Regulatory System in Alignment with ICH</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-03-01T20:32:25Z">1 March 2024</time> </div> <div class="tex2jax_process"><p>With the Chinese government initiating drug regulatory reform in 2015 and China joining the International Council for Harmonisation (ICH) in 2017, a significant number of measures have been implemented by the government. The aim is to make fundamental changes to China’s drug regulatory administration system so it can facilitate pharmaceutical development and better meet patient needs in the...</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-268585" data-history-node-id="268585" class="has-lead-form magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/march-april-2024/digital-display-labeling-clinical-supplies-clinical" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-03/0324_PE_MA_Hale_01.jpg?itok=5bp93bw-" width="1000" height="600" alt="Digital Display Labeling in Clinical Supplies for Clinical Trials" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Features</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/march-april-2024/digital-display-labeling-clinical-supplies-clinical" hreflang="en">Digital Display Labeling in Clinical Supplies for Clinical Trials</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-03-01T20:11:10Z">1 March 2024</time> </div> <div class="tex2jax_process"><p>Digital display labels (DDLs) offer an alternative solution to eliminate manual relabeling in the clinical supply chain, optimizing label content updates through a simple, system-controlled approach while providing new, uncharted opportunities. With increased efficiency in making regulatory-compliant changes and enhanced flexibility in the clinical supply chain, DDL technology has the...</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-265315" data-history-node-id="265315" class="has-lead-form magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/january-february-2024/quality-considerations-disaster-recovery-case" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-01/0124_PE_JF_Heinrichmann_01.jpg?itok=ZSZPS5mm" width="1000" height="600" alt="Quality Considerations in Disaster Recovery: A Case Study" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Features</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/january-february-2024/quality-considerations-disaster-recovery-case" hreflang="en">Quality Considerations in Disaster Recovery: A Case Study</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-01-01T14:20:00Z">1 January 2024</time> </div> <div class="tex2jax_process"><p>Due to the growing digitalization of the industry, we are highly dependent on information technology (IT) systems and data. The basic ability to execute our pharmaceutical business and decision-making processes relies on the permanent availability of these IT systems and data to ensure compliance and efficiency of our business operations. But numerous factors—including criminal activities,...</p></div> </div> </div> </article> </div> <footer> <div class="tex2jax_process"><div class="view-three-more"><a href="#" class="button full-width">View more > ></a></div></div> </footer> </div> </div> </section> <section class="views-element-container pemag-explore-list block-style-bold block-views-block-issue-list-block-1 block block-views block-views-blockissue-list-block-1" id="block-views-block-issue-list-block-1"> <h2 class="block-title">Explore</h2> <div><div class="row view--id-issue-list js-view-dom-id-e620bd3fafba7952f766482110d30981a0f01d2f2eb92adc725213b85378b269"> <div class="column medium-3 views-row"><div class="views-field views-field-nothing"><span class="field-content"><div> <a href="/pharmaceutical-engineering/topic/supply-chain" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/max_325x325/public/cover-images/topic_magazine_/2019-08/supply-chain_0.jpg?itok=vWZWC5Jn" width="300" height="300" 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</span></div></div> </div> </div> </section> <section class="views-element-container m-t-3 block-views-block-articles-block-25 block block-views block-views-blockarticles-block-25" id="block-views-block-articles-block-25"> <div><div class="view--id-articles js-view-dom-id-c5fd5fae714e1f0996eaf4cec767352cb26881bc7c1fc42bbb538609fdbaa2e0"> <div class="row"> <div class="columns small-12 medium-6 large-4 end"> <article id="node-272679" data-history-node-id="272679" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/white-papers/pharma-40-towards-itot-architectures-prescriptive-maintenance" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-06/digitization-Image%20by%20Gerd%20Altmann%20from%20Pixabay.jpg?itok=axg9ryHE" width="1000" height="600" alt="digitization-Image by Gerd Altmann from Pixabay" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">White Paper</div> <div class="magazine-title is-premium"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/white-papers/pharma-40-towards-itot-architectures-prescriptive-maintenance" hreflang="en">Pharma 4.0 – Towards IT/OT Architectures for Prescriptive Maintenance</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-03-01T18:48:52Z">1 March 2024</time> </div> <div class="tex2jax_process"><p>Faced with global competition and shrinking margins, (bio)pharmaceutical manufacturers worldwide are urged to increase production efficiency by making better use of time and resources. This is in addition to addressing the unique challenges faced by pharmaceutical manufacturers such as a strictly regulated environment, heterogeneous equipment suppliers, and long adaptation times....</p></div> </div> </div> </article> </div> <div class="columns small-12 medium-6 large-4 end"> <article id="node-272572" data-history-node-id="272572" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/white-papers/process-events-life-science-industry-information-model-concept-opc-ua" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-06/technology-Image%20by%20Tung%20Nguyen%20from%20Pixabay.jpg?itok=l3NBjjJI" width="1000" height="600" alt="technology-Image by Tung Nguyen from Pixabay" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">White Paper</div> <div class="magazine-title is-premium"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/white-papers/process-events-life-science-industry-information-model-concept-opc-ua" hreflang="en">Process Events for the Life Science Industry - Information Model Concept on OPC UA for Alarms and Audit Trails</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-02-01T19:27:46Z">1 February 2024</time> </div> <div class="tex2jax_process"><p>This Concept Paper proves that a standard model within OPC UA Alarms and Conditions (OPC UA Part 9) can be leveraged to realize Plug & Produce for exchanging pharmaceutical alarms and audit trails between OT manufacturing equipment and Orchestration Platforms or IT Services like EBR or Historian.</p></div> </div> </div> </article> </div> <div class="columns small-12 medium-6 large-4 end"> <article id="node-272571" data-history-node-id="272571" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/white-papers/simplified-integration-qualified-laboratory-devices-asset-administration" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-06/microscope-Image%20by%20Gerd%20Altmann%20from%20Pixabay.jpg?itok=_tM8Letv" width="1000" height="600" alt="microscope-Image by Gerd Altmann from Pixabay" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">White Paper</div> <div class="magazine-title is-premium"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/white-papers/simplified-integration-qualified-laboratory-devices-asset-administration" hreflang="en">A Simplified Integration of Qualified Laboratory Devices with the Asset Administration Shell as the Digital Twin</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2023-05-01T18:38:12Z">1 May 2023</time> </div> <div class="tex2jax_process"><p>This Concept Paper proves a laboratory device integration utilizing the Asset Administration Shell (AAS) metamodel (agnostic to the underlying technology and data structure).</p></div> </div> </div> </article> </div> </div> </div> </div> </section> <section id="block-dfptagpehomepagehousebillboardad" class="text-center block-dfptagpehomepagehousebillboardad block block-dfp block-dfp-ad1c754ead-21a0-4823-ba4f-f565aa84f96e"> <div id="js-dfp-tag-pe_homepage_house_billboard_ad"> <script type="text/javascript"> googletag.cmd.push(function() { googletag.display('js-dfp-tag-pe_homepage_house_billboard_ad'); }); </script> </div> </section> <section class="views-element-container block-style-bold m-t-3 block-views-block-articles-block-4 block block-views block-views-blockarticles-block-4" id="block-views-block-articles-block-4"> <h2 class="block-title">Latest Articles</h2> <div><div class="view--id-articles js-view-dom-id-1e93165eab335131fd224d3ecc83ee9c502dfae606c9ab7b499a0ca93ff15296"> <div class="views-row"> <article id="node-280159" data-history-node-id="280159" class="magazine-article-card pemag-teaser"> <div> <div class="row"> <div class="medium-6 columns"> <div class="field field--node-field-page-banner-image 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field--type-datetime field--label-hidden field__item"><time datetime="2024-11-26T22:43:35Z">26 November 2024</time> </div> <div class="tex2jax_process"><p>At the <a href="https://ispe.org/conferences/2024-annual-meeting-expo">2024 ISPE Annual Meeting & Expo</a> held in Orlando, Florida, USA, in October, a panel of global regulators and industry professionals addressed harmonization and regulatory convergence, digitalization, particularly the use of artificial intelligence (AI), and supply chain resilience.</p></div> </div> </div> </div> </article> </div> </div> </div> </section> <section class="views-element-container block-views-block-articles-block-5 block block-views block-views-blockarticles-block-5" id="block-views-block-articles-block-5"> <div><div class="row load-every-three view--id-articles js-view-dom-id-5b830765284ada9248f272a27a5be901aa922ea07d4ff508619726d3b7176ee4"> <div class="small-12 medium-4 columns views-row"> <article id="node-280158" data-history-node-id="280158" 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field--label-hidden field__item"><time datetime="2024-11-22T13:23:22Z">22 November 2024</time> </div> <div class="tex2jax_process"><p>The <a href="/node/267656" title="2025 ISPE Aseptic Conference" data-entity-type="node" data-entity-uuid="b5898b9a-caf7-47d9-a296-8c1b07f81e85" data-entity-substitution="canonical">2025 ISPE Aseptic Conference</a>, taking place 17 – 18 March 2025 in Washington, D.C., USA, has always been one of the more future-focused technical conferences within ISPE. 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For manufacturers, completing pharma facility and process optimization projects quickly and cost-effectively can be challenging. As a result, many are exploring new...</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279797" data-history-node-id="279797" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/ispeak/roger-nosal-recognized-richard-b-purdy-distinguished-achievement" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/Roger%20Nosal_Robert%20Purdy_IHS%20Award%20Image%203-750px.jpg?itok=-nLzz4wX" width="1000" height="600" alt="Roger Nosal_Robert Purdy - ISPE International Honor Awards" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">iSpeak Blog</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/ispeak/roger-nosal-recognized-richard-b-purdy-distinguished-achievement" hreflang="en">Roger Nosal Recognized with the Richard B. 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These awards provide the opportunity for the ISPE community to recognize and celebrate the dedicated professionals who volunteer countless hours to support ISPE and its mission.</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279684" data-history-node-id="279684" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/ispeak/embracing-authenticity-and-leadership-2024-ispe-annual-meeting" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/WIP%20Workshop%202024%20-%20AM-750px.jpg?itok=L3wRCuvs" width="1000" height="600" alt="Commander June Page and Captain Jill Hammond pause for a photo at the 2024 ISPE Annual Meeting & Expo following their participation in ISPE’s Women in Pharma® workshop, “Adaptable Leadership.”" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">iSpeak Blog</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/ispeak/embracing-authenticity-and-leadership-2024-ispe-annual-meeting" hreflang="en">Embracing Authenticity and Leadership at the 2024 ISPE Annual Meeting & Expo</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-12T19:32:04Z">12 November 2024</time> </div> <div class="tex2jax_process"><p>This year’s 2024 ISPE Annual Meeting & Expo at Gaylord Palms in Orlando, Florida, USA was an inspiring experience, combining the energy of high-level industry discussions, networking opportunities, and moments of genuine connection. Despite the uncertainty brought on by Hurricane Milton, the conference went forward with an impressive spirit of resilience and adaptability. From insightful...</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279667" data-history-node-id="279667" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/ispeak/beyond-automation-human-touch-industry-50" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/Automation-%20blog-750px.jpg?itok=QaqI1o_O" width="1000" height="600" alt="Automation - Human Touch in Industry 5.0" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">iSpeak Blog</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/ispeak/beyond-automation-human-touch-industry-50" hreflang="en">Beyond Automation: The Human Touch in Industry 5.0</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-12T13:23:07Z">12 November 2024</time> </div> <div class="tex2jax_process"><p>The future of manufacturing is not a battle between humans and machines. It is a collaboration that promises to redefine productivity and innovation. Industry 5.0 is poised to revolutionize how companies operate over the next decade, shifting the focus beyond mere automation and optimization to prioritizing the well-being of workers. This paradigm shift will transform workplaces, making them...</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279626" data-history-node-id="279626" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/ispeak/updated-ispe-hvac-guide-provides-support-professionals-all-levels" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/Good%20Practice%20Guide_Validation%20and%20Compliance%20-thumbnail_0%20%281%29_0.png?itok=JSY6HFPL" width="1000" height="600" alt="Updated ISPE HVAC Guide Provides Support for Professionals at All Levels of Experience " /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">iSpeak Blog</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/ispeak/updated-ispe-hvac-guide-provides-support-professionals-all-levels" hreflang="en">Updated ISPE HVAC Guide Provides Support for Professionals at All Levels of Experience </a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-11T14:37:41Z">11 November 2024</time> </div> <div class="tex2jax_process"><p>In September, ISPE released the second edition of their <a href="https://ispe.org/publications/guidance-documents/good-practice-guide-heating-ventilation-air-conditioning-second-edition">Good Practice Guide on Heating, Ventilation, and Air Conditioning (HVAC)</a>, which provides a detailed overview of HVAC considerations in the pharmaceutical industry. The second edition also reflects industry...</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279573" data-history-node-id="279573" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/ispeak/member-spotlight-daria-curtis" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/MemberSpotLight_v2.jpg?itok=YNUX3DHG" width="1000" height="600" alt="Member Spotlight: Daria Curtis" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">iSpeak Blog</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/ispeak/member-spotlight-daria-curtis" hreflang="en">Member Spotlight: Daria Curtis</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-08T21:05:27Z">8 November 2024</time> </div> <div class="tex2jax_process"><p>Daria Curtis works in quality assurance validation at AstraZeneca and is a member of ISPE. In this interview, conducted by Edyna Miguez, Membership Growth Manager at ISPE, Curtis shares her key areas of expertise, what prompted her to get involved with ISPE, how being a member has enhanced her professional career, and more.</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279490" data-history-node-id="279490" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/ispeak/exploring-future-atmp-manufacturing-digitalization-navigating" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/medical-banner-with-doctor-wearing-equipment-750px.jpg?itok=xWH2ClQw" width="1000" height="600" alt="Exploring the Future of ATMP Manufacturing from Digitalization to Navigating Regulations" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">iSpeak Blog</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/ispeak/exploring-future-atmp-manufacturing-digitalization-navigating" hreflang="en">Exploring the Future of ATMP Manufacturing from Digitalization to Navigating Regulations</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-07T13:55:25Z">7 November 2024</time> </div> <div class="tex2jax_process"><p>In an era where advanced therapy medicinal products (ATMPs) are revolutionizing healthcare, the <a href="/node/263581" title="2024 ISPE Pharma 4.0™ and Annex 1 Conference" data-entity-type="node" data-entity-uuid="6b7f4309-c288-4bba-9aeb-73c7768503cd" data-entity-substitution="canonical">2024 ISPE Pharma 4.0™ and Annex 1 Conference</a>, taking place 10-11 December in Rome, Italy, and...</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279387" data-history-node-id="279387" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/ispeak/ispe-emerging-leaders-member-spotlight-rebecca-roscher" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/FOYA-banquet-750px.jpg?itok=xymuoDM9" width="1000" height="600" alt="ISPE International Board of Directors at FOYA-banquet-2024" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">iSpeak Blog</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/ispeak/ispe-emerging-leaders-member-spotlight-rebecca-roscher" hreflang="en">ISPE Emerging Leaders Member Spotlight on Rebecca Roscher</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-05T11:28:16Z">5 November 2024</time> </div> <div class="tex2jax_process"><p>In this blog post, Rebecca Roscher – Project Manager at Bayer AG (Supply Center Grenzach) – shares how she rose from an ISPE student member to an Emerging Leader Representative, Ex-Officio, on the 2024-2025 ISPE International Board of Directors.</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279570" data-history-node-id="279570" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/november-december-2024/japan-affiliate-emerging-leaders-activities" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/1124_PE_ND_P%2BE_12.jpg?itok=jDyUc6ZR" width="1000" height="600" alt="Japan Affiliate Emerging Leaders Activities" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">InTouch</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/november-december-2024/japan-affiliate-emerging-leaders-activities" hreflang="en">Japan Affiliate Emerging Leaders Activities</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-01T14:25:00Z">1 November 2024</time> </div> <div class="tex2jax_process"><p>The ISPE Japan Affiliate held the “Young Professionals Seminar” to support the growth of recent graduates. Starting on 14 July 2023, this seminar spanned four sessions and took place at the Nihonbashi Life Science Building and Taiyo Pharma Tech Takatsuki Plant. Led by ISPE Emerging Leaders, the seminar aimed to cultivate the next generation of leaders in the pharmaceutical industry.</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279569" data-history-node-id="279569" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/november-december-2024/ispe-announces-sustainability-community-practice" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/1124_PE_ND_P%2BE_01_1.jpg?itok=4hC2yMTb" width="1000" height="600" alt="ISPE Announces Sustainability Community of Practice" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">InTouch</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/november-december-2024/ispe-announces-sustainability-community-practice" hreflang="en">ISPE Announces Sustainability Community of Practice</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-01T14:10:00Z">1 November 2024</time> </div> <div class="tex2jax_process"><p>Governments around the world have made international commitments to reduce their environmental impact and protect nature. Policy frameworks have been established to facilitate and drive progress against agreed-upon targets. These directly impact end-to-end activities for the biopharmaceutical, pharmaceutical, and medical device sectors, including research and development, manufacturing,...</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279493" data-history-node-id="279493" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/november-december-2024/setting-net-zero-targets-tangible-benefits" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/1124_PE_ND_Shah_05.png?itok=LY_Sqctl" width="1000" height="600" alt="Setting Net-Zero Targets: Tangible Benefits of Sustainability" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Technical</div> <div class="magazine-title is-premium"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/november-december-2024/setting-net-zero-targets-tangible-benefits" hreflang="en">Setting Net-Zero Targets: Tangible Benefits of Sustainability</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-01T14:06:13Z">1 November 2024</time> </div> <div class="tex2jax_process"><p>Many organizations are on the right path to sustainability, but more can still be done— especially for setting and meeting net-zero targets. Although a commitment to net-zero operations is important for all industries, it’s particularly necessary for the pharmaceutical industry, with its high energy consumption, high water demands, and the use of solvents for manufacturing.</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279566" data-history-node-id="279566" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/november-december-2024/pharmaceutical-engineeringr-article-wins-2024" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/1124_PE_ND_P%2BE_11.jpg?itok=p_lMy6e9" width="1000" height="600" alt="Pharmaceutical Engineering® Article Wins 2024 APEX Award" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">InTouch</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/november-december-2024/pharmaceutical-engineeringr-article-wins-2024" hreflang="en">Pharmaceutical Engineering® Article Wins 2024 APEX Award</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-01T14:05:00Z">1 November 2024</time> </div> <div class="tex2jax_process"><p>ISPE has been honored with a 2024 APEX Award of Excellence in Writing for “ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma” by Frederick Blumenthal, Martin Heitmann, Stefan Münch, and Brandi Stockton published in the July/August 2023 issue of Pharmaceutical Engineering®.</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279565" data-history-node-id="279565" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/november-december-2024/ispe-announces-ispe-air" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/1124_PE_ND_P%2BE_01_0.jpg?itok=oan_5uv-" width="1000" height="600" alt="ISPE AI®" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">InTouch</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/november-december-2024/ispe-announces-ispe-air" hreflang="en">ISPE Announces ISPE AI®</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-01T14:00:00Z">1 November 2024</time> </div> <div class="tex2jax_process"><p>ISPE recently announced <a href="/Communities-Practice" title="Communities of Practice" data-entity-type="node" data-entity-uuid="d958ba74-a1fd-41e8-8570-7c34c319690a" data-entity-substitution="canonical">ISPE AI<sup>®</sup></a>, an initiative aimed at aiding the pharmaceutical industry in realizing the potential of artificial intelligence (AI). The initiative will include a multifaceted approach to...</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279560" data-history-node-id="279560" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/november-december-2024/meet-ispe-staff-nada-elsayed" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/meet-staff-Nada.jpg?itok=KN9yB6zl" width="1000" height="600" alt="Meet the ISPE Staff: Nada Elsayed" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">InTouch</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/november-december-2024/meet-ispe-staff-nada-elsayed" hreflang="en">Meet the ISPE Staff: Nada Elsayed</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-01T13:20:00Z">1 November 2024</time> </div> <div class="tex2jax_process"><p>In each issue of Pharmaceutical Engineering<sup>®</sup>, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Nada Elsayed, Content Development Manager on the Publications Team.</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279559" data-history-node-id="279559" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/november-december-2024/glance-foundation-news" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/1124_PE_ND_P%2BE_09.jpg?itok=vyT2JOn3" width="1000" height="600" alt="Emerging Leaders" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">InTouch</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/november-december-2024/glance-foundation-news" hreflang="en">At a Glance: Foundation News</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-01T13:12:00Z">1 November 2024</time> </div> <div class="tex2jax_process"><p>This year, the ISPE Foundation’s Professional Development Grants program, supported by the Moderna Foundation, enabled 24 STEM students and Emerging Leaders to attend the 2024 ISPE Annual Meeting & Expo with all expenses covered.</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279568" data-history-node-id="279568" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/november-december-2024/memoriam-antonio-tony-r-moreira-phd-and-james-jim" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/Tony%20Moreira%20Family_Joseph%20Philips%20IHS%20Award_750px_0.jpg?itok=DRGRRUoy" width="1000" height="600" alt="In Memoriam: Antonio (Tony) R. Moreira, PhD, and James (Jim) O’Brien" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">InTouch</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/november-december-2024/memoriam-antonio-tony-r-moreira-phd-and-james-jim" hreflang="en">In Memoriam: Antonio (Tony) R. Moreira, PhD, and James (Jim) O’Brien</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-01T13:00:00Z">1 November 2024</time> </div> <div class="tex2jax_process"><p>We lost two members of the ISPE family this year, both of whom played instrumental roles in shaping the pharmaceutical industry and ISPE.</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279418" data-history-node-id="279418" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/november-december-2024/guest-column-leadership-art-and-science" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/Lou%20Schmukler.jpg?itok=83F3YCP3" width="1000" height="600" alt="Guest Column: Louis S. Schmukler" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Insights</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/november-december-2024/guest-column-leadership-art-and-science" hreflang="en">Guest Column: Leadership as Art and Science</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-01T12:12:00Z">1 November 2024</time> </div> <div class="tex2jax_process"><p>I am enthusiastic and humbled to have the opportunity to author a column on leadership for the ISPE membership. The subject of leadership has been a passion of mine since the very start of my career, 45 years ago. From the shop floor to the C-suite, I have been an ardent student of the subject.</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279417" data-history-node-id="279417" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/november-december-2024/emerging-leaders-editorial-sustainability-and" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/emerging-leaders-Monique%20Sprueill-V2.jpg?itok=0W5bUK8q" width="1000" height="600" alt="Emerging Leaders Editorial: Monique L. Sprueill" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Insights</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/november-december-2024/emerging-leaders-editorial-sustainability-and" hreflang="en">Emerging Leaders Editorial: Sustainability and Opportunities for Emerging Leaders</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-01T12:10:00Z">1 November 2024</time> </div> <div class="tex2jax_process"><p>The pharmaceutical, biotechnology, and medical device industries continue to grow as patients require more access to medicine, data that allows them to make informed decisions, and personalized care. Achieving sustainability across the supply chain while adhering to quality compliance requirements presents a challenge.</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279416" data-history-node-id="279416" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/november-december-2024/women-pharmar-editorial-year-remarkable" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/message-wip-vs-2021.jpg?itok=j8iuTio0" width="1000" height="600" alt="Women in Pharma® Editorial: Vivien Santillan" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Insights</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/november-december-2024/women-pharmar-editorial-year-remarkable" hreflang="en">Women in Pharma® Editorial: A Year of Remarkable Achievements</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-01T12:05:00Z">1 November 2024</time> </div> <div class="tex2jax_process"><p>As we approach the end of another impactful year, it is a pleasure to reflect on the outstanding achievements and contributions of ISPE’s Women in Pharma community, both regionally and internationally.</p></div> </div> </div> </article> </div> <div class="small-12 medium-4 columns views-row"> <article id="node-279415" data-history-node-id="279415" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/november-december-2024/message-chair-ispe-2024-reflecting-another-great" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-11/Board-Chair_Scott%20Billman_0.jpg?itok=6wum8bz-" width="1000" height="600" alt="Message from the Chair: Scott W. Billman" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Insights</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/november-december-2024/message-chair-ispe-2024-reflecting-another-great" hreflang="en">Message from the Chair: ISPE 2024 - Reflecting on Another Great Year</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-01T12:00:00Z">1 November 2024</time> </div> <div class="tex2jax_process"><p>As we come out of the <a href="/node/257508" title="2024 ISPE Annual Meeting & Expo" data-entity-type="node" data-entity-uuid="e9a2b11b-4a74-4e33-9fc1-9eddbf4225ff" data-entity-substitution="canonical">2024 ISPE Annual Meeting & Expo</a> and move toward the end of the year, I find myself looking back and reflecting on what the ISPE community has accomplished over the past year.</p></div> </div> </div> </article> </div> <footer> <div class="tex2jax_process"><div class="view-three-more"><a href="#" class="button full-width">View more > ></a></div></div> </footer> </div> </div> </section> <section class="views-element-container block-views-block-articles-block-6 block block-views block-views-blockarticles-block-6" id="block-views-block-articles-block-6"> <div><div class="pemag-featured-sponsored-content view--id-articles js-view-dom-id-c53b61ffa4af96a8511b8b526803a7654583b6b4ec5545a3bc2313b2cea8d7bf"> <header> <div class="tex2jax_process"><div class="block-blue p-a-1 m-b-1"> <p> <strong>Sponsored content is the sole responsibility of the authors and is not endorsed, reviewed, nor a published article of Pharmaceutical Engineering® magazine or ISPE.</strong> </p> </div></div> </header> <div class="row"> <div class="views-row columns small-12 medium-6"> <article id="node-279257" data-history-node-id="279257" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/energy-optimized-cleanroom-planning" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-10/Zeta-Hero-image_Final.jpg?itok=dCkNeyfZ" width="1000" height="600" alt="Zeta Hero" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Sponsored Content</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/energy-optimized-cleanroom-planning" hreflang="en">Energy-Optimized Cleanroom Planning</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-01T10:00:00Z">1 November 2024</time> </div> <div class="tex2jax_process"><p>Cleanroom technology is a particularly promising starting point when it comes to energy optimization. ZETA has developed an innovative method for planning cleanrooms in a process-based and energy-optimized way, and one thing is clear: simulations play a central role in this pioneering approach.</p></div> </div> </div> </article> </div> <div class="views-row columns small-12 medium-6"> <article id="node-279259" data-history-node-id="279259" class="magazine-article-card"> <div class="view-mode-callout"> <div class="section-image"> <div class="field field--node-field-page-banner-image field--name-field-page-banner-image field--type-image field--label-hidden field__item"> <a href="/pharmaceutical-engineering/development-anomaly-detection-algorithm-predictive-maintenance" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/2024-10/Telstar-nov24-750px.jpg?itok=z_hovvji" width="1000" height="600" alt="Telstar banner" /> </a> </div> </div> <div class="section-content"> <div class="field field--node-field-story-type field--name-field-story-type field--type-list-string field--label-hidden field__item">Sponsored Content</div> <div class="magazine-title is-unlocked"> <div class="field field--node-title field--name-title field--type-string field--label-hidden field__item"><a href="/pharmaceutical-engineering/development-anomaly-detection-algorithm-predictive-maintenance" hreflang="en">Development of an Anomaly Detection Algorithm for Predictive Maintenance in Lyophilization Systems</a></div> </div> <div class="field field--node-field-publish-date field--name-field-publish-date field--type-datetime field--label-hidden field__item"><time datetime="2024-11-01T10:00:00Z">1 November 2024</time> </div> <div class="tex2jax_process"><p>This paper focuses on the development of a diagnostic tool for predictive maintenance in industrial lyophilization systems. At the core of the system is an anomaly detection algorithm designed to identify abnormal patterns in operational data. Through its development, key diagnostic strategies have been identified to improve system reliability and early failure detection, ultimately aiming to...</p></div> </div> </div> </article> </div> </div> </div> </div> </section> <section class="views-element-container block-style-bold block-views-block-mag-current-issue-block-1 block block-views block-views-blockmag-current-issue-block-1" id="block-views-block-mag-current-issue-block-1"> <h2 class="block-title">Current Issue</h2> <div><div class="view--id-mag-current-issue js-view-dom-id-acc6a55bd1ca9497b4567fa2e21cf6aab8d331e55ffde43f78eb42a22a6615fe"> <div><div class="views-field views-field-nothing"><span class="field-content"><div class="columns medium-4"> <a href="/pharmaceutical-engineering/november-december-2024" hreflang="en"><img loading="lazy" src="/sites/default/files/styles/teaser_image/public/mag_issue/2024-11/PE%20Mag_750px.jpg?itok=8ZOW8i8q" width="1000" height="600" alt="Pharmaceutical Engineering" /> </a> </div> <div class="columns medium-8"> <h2><a href="/pharmaceutical-engineering/november-december-2024" hreflang="en">November / December 2024</a></h2> <div class="tex2jax_process">Plastic Process Waste in Biopharmaceutical Manufacturing Cover: This article presents a comprehensive analysis of plastic waste generation in the biopharmaceutical industry, focusing on using single-use technologies (SUT) in bioprocessing for monoclonal antibody (mAb) production. It aims to inform sustainable practices within the biopharmaceutical industry and to encourage the development of more...</div> </div></span></div></div> </div> </div> </section> </section> <section id="block-ispe-content" class="block-ispe-content block block-system block-system-main-block"> <article id="node-172639" data-history-node-id="172639" class="node node--type-page node--promoted node--view-mode-full"> <div class="view-mode-full"> </div> </article> </section> <section id="block-socialshareblock" class="block-socialshareblock block block-ispe-social-block block-social-block"> <div class="share-this show-for-large"></div> </section> </div> </section> </main> <aside id="sidebar" class="" > </aside> </div> <div id="featured-bottom" class="featured-bottom-wrapper"> <div class="region--featured-bottom region region--featured_bottom"> <section id="block-membershipcallout" class="block-membershipcallout callout-block"> <div class="callout-full callout-blue"> <div class="row"> <div class="columns callout-content-wrapper"> <div class="callout-content columns small-12 medium-12 large-5"> <div class="tex2jax_process"><h3>Not a Member Yet?</h3> <p>Whether networking at events or collaborating through our Communities of Practice, the value of an ISPE membership is in the connections made between pharmaceutical industry professionals and Regulators to collaborate on solutions to common goals and challenges.</p> <p><a class="button" data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="0b723b42-150e-4494-94bf-b6068f3da38e" href="/membership/join" title="Become part of a driving force. 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