Orphan Drugs - Catalent

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class="dcsbcm_separator"> » </span><span class="dcsbcm_divi_breadcrumb dcsbcm_divi_breadcrumb-active">Orphan Drugs</span></ol> </div> </div> </div> </div> </div><div class="et_pb_section et_pb_section_1 et_section_regular" > <div class="et_pb_row et_pb_row_1"> <div class="et_pb_column et_pb_column_3_4 et_pb_column_1 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module mugo_catalent_title mugo_catalent_title_0"> <div class="et_pb_module_inner"> <div class="ctl-title"> <div class="title-image image-large"> <img decoding="async" src="https://www.catalent.com/wp-content/uploads/2020/10/Orphan_59x59.png" alt="Orphan icon" /> </div> <div class="title-content" style="color:#332a86 !important;"> <h1>Orphan Drugs</h1> </div> </div> </div> </div><div class="et_pb_module et_pb_text et_pb_text_0 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p>FLEXIBLE SCALE.<br />ACCELERATED SOLUTIONS.<br />BROADEST ADVANCED DELIVERY TECHNOLOGIES.</p></div> </div> </div><div class="et_pb_column et_pb_column_1_4 et_pb_column_2 et_pb_css_mix_blend_mode_passthrough et-last-child et_pb_column_empty"> </div> </div> </div><div class="et_pb_section et_pb_section_2 et_section_specialty" > <div class="et_pb_row"> <div class="et_pb_column et_pb_column_3_4 et_pb_column_3 et_pb_specialty_column et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_row_inner et_pb_row_inner_0"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_inner et_pb_column_inner_0 et-last-child"> <div class="et_pb_module et_pb_text et_pb_text_1 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h5><a style="color: #000000;text-decoration: underline" href="#rare-diseases">Rare Diseases at a Glance</a>      <a style="color: #000000;text-decoration: underline" href="#accelerated-development">Accelerated Development</a>      <a style="color: #000000;text-decoration: underline" href="#advanced-drug-delivery-technologies">Advanced Drug Delivery Technologies</a>      <a style="color: #000000;text-decoration: underline" href="#flexible-manufacturing">Flexible Manufacturing at Customized Scale</a></h5></div> </div><div class="et_pb_module et_pb_divider et_pb_divider_0 et_pb_divider_position_ et_pb_space"><div class="et_pb_divider_internal"></div></div><div class="et_pb_module et_pb_text et_pb_text_2 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p> <a name="rare-diseases"></a><a class="back-to-top" href="#top">Back to top</a></p> <h4>RARE DISEASES AT A GLANCE</h4></div> </div><div class="et_pb_module et_pb_image et_pb_image_0"> <span class="et_pb_image_wrap "><img fetchpriority="high" decoding="async" width="800" height="381" src="https://www.catalent.com/wp-content/uploads/2020/10/RareDiseases.png" alt="" title="RareDiseases" srcset="https://www.catalent.com/wp-content/uploads/2020/10/RareDiseases.png 800w, https://www.catalent.com/wp-content/uploads/2020/10/RareDiseases-480x229.png 480w" sizes="(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) 800px, 100vw" class="wp-image-225674" /></span> </div><div class="et_pb_module et_pb_image et_pb_image_1"> <span class="et_pb_image_wrap "><img loading="lazy" decoding="async" width="400" height="380" src="https://www.catalent.com/wp-content/uploads/2020/10/RareDisease_indv_1.png" alt="" title="RareDisease_indv_1" srcset="https://www.catalent.com/wp-content/uploads/2020/10/RareDisease_indv_1.png 400w, https://www.catalent.com/wp-content/uploads/2020/10/RareDisease_indv_1-300x285.png 300w" sizes="(max-width: 400px) 100vw, 400px" class="wp-image-225700" /></span> </div><div class="et_pb_module et_pb_image et_pb_image_2"> <span class="et_pb_image_wrap "><img loading="lazy" decoding="async" width="400" height="380" src="https://www.catalent.com/wp-content/uploads/2020/10/RareDisease_indv_2.png" alt="" title="RareDisease_indv_2" srcset="https://www.catalent.com/wp-content/uploads/2020/10/RareDisease_indv_2.png 400w, https://www.catalent.com/wp-content/uploads/2020/10/RareDisease_indv_2-300x285.png 300w" sizes="(max-width: 400px) 100vw, 400px" class="wp-image-225701" /></span> </div><div class="et_pb_module et_pb_image et_pb_image_3"> <span class="et_pb_image_wrap "><img loading="lazy" decoding="async" width="400" height="380" src="https://www.catalent.com/wp-content/uploads/2020/10/RareDisease_indv_3.png" alt="" title="RareDisease_indv_3" srcset="https://www.catalent.com/wp-content/uploads/2020/10/RareDisease_indv_3.png 400w, https://www.catalent.com/wp-content/uploads/2020/10/RareDisease_indv_3-300x285.png 300w" sizes="(max-width: 400px) 100vw, 400px" class="wp-image-225702" /></span> </div><div class="et_pb_module et_pb_image et_pb_image_4"> <span class="et_pb_image_wrap "><img loading="lazy" decoding="async" width="400" height="380" src="https://www.catalent.com/wp-content/uploads/2020/10/RareDisease_indv_4.png" alt="" title="RareDisease_indv_4" srcset="https://www.catalent.com/wp-content/uploads/2020/10/RareDisease_indv_4.png 400w, https://www.catalent.com/wp-content/uploads/2020/10/RareDisease_indv_4-300x285.png 300w" sizes="(max-width: 400px) 100vw, 400px" class="wp-image-225703" /></span> </div><div class="et_pb_module et_pb_image et_pb_image_5"> <span class="et_pb_image_wrap "><img loading="lazy" decoding="async" width="400" height="380" src="https://www.catalent.com/wp-content/uploads/2020/10/RareDisease_indv_5.png" alt="" title="RareDisease_indv_5" srcset="https://www.catalent.com/wp-content/uploads/2020/10/RareDisease_indv_5.png 400w, https://www.catalent.com/wp-content/uploads/2020/10/RareDisease_indv_5-300x285.png 300w" sizes="(max-width: 400px) 100vw, 400px" class="wp-image-225704" /></span> </div><div class="et_pb_module et_pb_text et_pb_text_3 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p style="color: #016ba9">Catalent has extensive experience in advancing hundreds of orphan, rare, breakthrough and accelerated designation molecules employing multiple technologies. From formulation development to patient-focused dose design to flexible supply, partnering with Catalent reduces risk, accelerates scale-up and helps transform science and innovation into better real-world patient treatments.</p> <p>From metabolic and neurological disorders to rare diseases linked to single gene deficiencies, Catalent has touched more than 100 orphan drug treatments over the past few years.</p> <p style="padding-bottom: 1em">As the global leader in drug development, delivery and manufacturing solutions, Catalent has the customized scale and expertise to meet the aggressive timelines desirable for accelerated regulatory approval and commercial success of your orphan drug product across a range of treatment modalities.</p> <ul style="padding-bottom:0px"> <li><a href="https://www.catalent.com/oral-dose/">Oral Dose</a></li> <li><a href="https://biologics.catalent.com/biologics/">Biologics</a></li> <li><a href="https://biologics.catalent.com/cell-therapy/">Cell Therapy</a></li> <li><a href="https://biologics.catalent.com/gene-therapy/">Gene Therapy</a></li> <li><a href="https://www.catalent.com/specialty/">Specialty Delivery </a></li> </ul></div> </div><div class="et_pb_module et_pb_divider et_pb_divider_1 et_pb_divider_position_ et_pb_space"><div class="et_pb_divider_internal"></div></div><div class="et_pb_module et_pb_text et_pb_text_4 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p> <a name="accelerated-development"></a><a class="back-to-top" href="#top">Back to top</a></p> <h4>ACCELERATED DEVELOPMENT</h4></div> </div><div class="et_pb_module et_pb_text et_pb_text_5 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p>The pressure to get orphan drug development right on the first attempt can be intense and stressful, especially if the therapy being developed is lifesaving and the first of its kind.</p> <p>To successfully develop effective treatments for rare diseases faster, it is often important to supplement the innovator’s expertise with broader experience in formulation and specialized drug delivery technologies. Working with the number one global leader in drug development can guide you to the right decisions at every phase. It is the best way to accelerate development, avoid costly rework and improve the quality of future treatments.</p> <p>With over 85 years of experience developing world-class formulations for innovators around the globe, Catalent has proven scientific, regulatory, and product development expertise to support a vast range of orphan projects – from <a href="https://www.catalent.com/oral-dose/development-bioavailability/">small molecule</a> to biologics and <a href="https://biologics.catalent.com/cell-therapy/process-industrialization/process-development-and-diagnosis/">cell</a> and <a href="https://biologics.catalent.com/gene-therapy/process-development/">gene therapy</a>.</p> <p>Our deep expertise in solving simple to complex formulation challenges with commercially scalable technologies ensures effortless scale-up and timeliness of the manufacturing process.</p> <p>Whether you have a small molecule, biologic, cell or gene therapy candidate, we offer integrated solutions to accelerate, de-risk and simplify your development path to clinic and beyond.</p> <ul> <li><a href="https://www.catalent.com/oral-dose/development-bioavailability/preclinical-development/optiform-solution-suite/">OptiForm® Solution Suite</a> – Accelerate Your Small Molecule from Candidate Selection to Phase 1</li> <li><a href="https://www.catalent.com/oral-dose/oral-technologies/oral-macromolecule-delivery/optiform-solution-suite-bio/">OptiForm® Solution Suite (Bio)</a> – Fast Macromolecule Screening for Oral Delivery </li> <li><a href="https://biologics.catalent.com/biologics/onebio-integrated-suite/">OneBio® Integrated Suite</a> – Single Solution from Cell Line Development to Clinical Supply and beyond</li> <li><a href="https://clinical.catalent.com/solutions/optiform-total-supply/">OptiForm® Total Supply</a> – Integrated Development, Manufacturing and Clinical Supply Solution</li> </ul> <p>With state-of-the-art facilities, 25+ R&D teams and 40+ manufacturing and clinical locations around the world, we are ready to partner on delivering your orphan product to market faster, utilizing our site-to-site connectivity to enable a seamless continuum of service from development to supply.</p></div> </div><div class="et_pb_module et_pb_divider et_pb_divider_2 et_pb_divider_position_ et_pb_space"><div class="et_pb_divider_internal"></div></div><div class="et_pb_module et_pb_text et_pb_text_6 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><a name="advanced-drug-delivery-technologies"></a><a class="back-to-top" href="#top">Back to top</a></p> <h4>ADVANCED DRUG DELIVERY TECHNOLOGIES</h4></div> </div><div class="et_pb_module et_pb_text et_pb_text_7 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p>Catalent strives to develop patient centric and commercially successful treatments that deliver optimal outcomes for innovators, prescribers, and patients.</p> <p style="padding-bottom: 1em">Our experience in developing thousands of therapies is backed by the broadest selection of drug delivery technologies and the ability to overcome a variety of drug delivery challenges including dose loading, taste masking, drug release and food effects.</p> <ul> <li><a href="https://www.catalent.com/oral-dose/oral-technologies/">Oral Solid Dose</em></strong> & <a href="https://www.catalent.com/oral-dose/softgel-technologies/">Softgel Technologies</a></li> <li><a href="https://biologics.catalent.com/biologics/drug-product/vial-filling-lyophilization/">Biologics Vials & Syringes</a></li> <li><a href="https://biologics.catalent.com/cell-therapy/cgmp-manufacturing/fill-finish/">Cell Therapy Fill / Finish</a></li> <li><a href="https://biologics.catalent.com/gene-therapy/cgmp-manufacturing/fill-finish/">Gene Therapy Fill / Finish</a></li> <li><a href="https://www.catalent.com/specialty/">Specialty Delivery Technologies</a></li> </ul></div> </div><div class="et_pb_module et_pb_divider et_pb_divider_3 et_pb_divider_position_ et_pb_space"><div class="et_pb_divider_internal"></div></div><div class="et_pb_module et_pb_text et_pb_text_8 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><a name="flexible-manufacturing"></a><a class="back-to-top" href="#top">Back to top</a></p> <h4>FLEXIBLE MANUFACTURING AT CUSTOMIZED SCALE</h4></div> </div><div class="et_pb_module et_pb_text et_pb_text_9 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p>Flexibility and adaptability are critical for accelerated programs (i.e., orphan drugs, fast track, breakthrough therapy, accelerated approvals, and priority review) and oncology drugs, as they require smaller batch sizes, expedited development and manufacturing timelines, and the ability to efficiently adjust production volumes to meet market demands.</p> <p>With our tightly integrated network of development, clinical supply, and manufacturing sites, Catalent has the right scale and expertise to reduce risk between phases and meet the aggressive timelines desirable for accelerated regulatory approval and commercial success.</p> <ul> <li><a href="https://www.catalent.com/oral-dose/oral-manufacturing/onexpress">OneXpress® Solution</a> – Small Molecules</li> <li><a href="https://biologics.catalent.com/biologics/onebio-integrated-suite/">OneBio® Integrated Suite</a> – Biologics</li> <li><a href="https://biologics.catalent.com/cell-therapy/integrated-solutions/">Integrated Solutions for Cell & Gene Therapy</a></li> </ul> <p>Catalent has invested in customized suites and end-to-end solutions to provide customers with ample flexibility to meet their specific project needs. We offer a variety of equipment scales to meet your demand, at every stage of the product lifecycle.</p> <p>With our manufacturing expertise, breadth of scalable development and delivery technologies, and our exceptional quality standards, we can support your program requirements with reliable supply to global markets.</p></div> </div><div class="et_pb_module et_pb_divider et_pb_divider_4 et_pb_divider_position_ et_pb_space"><div class="et_pb_divider_internal"></div></div><div class="et_pb_module et_pb_text et_pb_text_10 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner">OPTIFORM and ONEBIO are registered trademarks and ONEXPRESS is a trademark of Catalent, Inc. or its affiliates or subsidiaries.</p> <p><strong><em><u>References:</u></em></strong></p> <p>a.) Nguengang Wakap, S., Lambert, D.M., Olry, A. et al. Estimating cumulative point prevalence of rare diseases: analysis of the Orphanet database. Eur J Hum Genet 28, 165–173. 2020: <u>https://doi.org/10.1038/s41431-019-0508-0 </u></p> <p>b.) U.S. FDA, Orphan Drug List Access Portal. Searched on July 1, 2020: <u>https://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm </u></p> <p>c.) Spotlight on rare diseases, The Lancet Diabetes & Endocrinology, vol. 7 issue 2. 2019. pp: 75</p> <p>d.) Parihar, Shweta, Jain, Vipresha. IQVIA Blog, “Orphan Drugs: A Spotlight on Rare Diseases,” January 13, 2020: <u>https://www.iqvia.com/blogs/2020/01/orphan-drugs-a-spotlight-on-rare-diseases </u></div> </div><div class="et_pb_module et_pb_divider et_pb_divider_5 et_pb_divider_position_ et_pb_space"><div class="et_pb_divider_internal"></div></div> </div> </div> </div><div class="et_pb_column et_pb_column_1_4 et_pb_column_4 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module et_pb_text et_pb_text_11 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h4>EXPERT CONTENT</h4></div> </div><div class="et_pb_module et_pb_text et_pb_text_12 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><a href="https://www.catalent.com/expert-content/development-bioavailability/the-future-of-orphan-drugs-insights-on-the-current-market-trends-strategic-partnerships-driving-innovation/">Industry Trend Report – The Future of Orphan Drugs</a></p> <p><a href="https://www.catalent.com/expert-content/development-bioavailability/next-generation-orphan-drug-delivery/">eBook – Next-Generation Orphan Drug Delivery</a></p> <p><a href="https://clinical.catalent.com/expert-content/expanded-access-and-commercial-packaging-strategies-for-orphan-niche-and-low-volume-drugs-2/">Executive Summary – Expanded Access and Commercial Packaging Strategies for Orphan, Niche, and Low-Volume Drugs</a></p> </ol></div> </div><div class="et_pb_module et_pb_text et_pb_text_13 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h4>RELATED TOPICS</h4></div> </div><div class="et_pb_module et_pb_text et_pb_text_14 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><a href="https://www.catalent.com/oral-dose/development-bioavailability/preclinical-development/optiform-solution-suite/">OptiForm® Solution Suite</a></p> <p><a href="https://www.catalent.com/oral-dose/oral-technologies/oral-macromolecule-delivery/optiform-solution-suite-bio/">OptiForm® Solution Suite (Bio)</a></p> <p><a href="https://biologics.catalent.com/biologics/onebio-integrated-suite/">OneBio® Integrated Suite</a></p> <p><a href="https://biologics.catalent.com/cell-therapy/integrated-solutions/">Integrated Solutions for Cell & Gene Therapy</a></p> <p><a href="https://clinical.catalent.com/solutions/optiform-total-supply/">OptiForm® Total Supply</a></p></div> </div><div class="et_pb_button_module_wrapper et_pb_button_0_wrapper et_pb_button_alignment_center et_pb_module "> <a class="et_pb_button et_pb_button_0 et_pb_bg_layout_light" href="https://www.catalent.com/contact-us/" data-icon="5">Contact Us</a> </div> </div> </div> </div> </div> </div> </div> </article> </div> <footer data-wpr-lazyrender="1" id="catalent-footer" class="catalent-footer"> <div class="container"> <div class="row sec-main-menu"> <nav class="main-menu" aria-label="Footer menu"> <a href="https://www.catalent.com/expert-content/" title="Expert Content" >Expert Content</a> <a href="https://www.catalent.com/email-subscribe/" title="Subscribe" >Subscribe</a> <a href="https://investor.catalent.com/" title="Investors" >Investors</a> <a href="https://www.catalent.com/careers/" title="Careers" >Careers</a> <a href="https://www.catalent.com/contact-us/" title="Contact Us" >Contact Us</a> <a href="https://www.catalent.com/site-map/" title="Site Map" >Site Map</a> </nav> <nav class="social-menu" aria-label="Social Media menu"> <div class="sec-title">Follow Us. 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