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whiteHeader"><div class="navigationWrapper"><div class="navigationInner"><a class="logo" title="Körber Pharma" href="/en/"><img class="logo-normal" title="Körber Pharma" alt="Körber Pharma" src="/typo3conf/ext/provider/Resources/Public/Frontend/Images/logo.svg" width="1700" height="1000" loading="lazy" /><img class="logo-inverse" title="Körber Pharma" alt="Körber Pharma" src="/typo3conf/ext/provider/Resources/Public/Frontend/Images/logo-white.svg" width="1700" height="1000" loading="lazy" /></a><nav class="mainNavigationArea"><ul class="navPrimary"><li class=" has-sub hasChildrenMainHeader" data-megaMenu-link="page-189" ><a href="/en/solutions" title="Solutions & Services"> Solutions & Services </a></li><li class=" " data-megaMenu-link="page-3159" ><a href="/en/customer-success" title="Customer Success"> Customer Success </a></li><li class=" " data-megaMenu-link="page-3178" ><a href="/en/sustainability" title="Sustainability"> Sustainability </a></li><li class=" " 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data-megaContent-link="page-189-overview"><button class="current"> Overview </button></li><li class="hasChildrenHeader" data-megaContent-link="page-197"><button> Software solutions </button></li><li class="hasChildrenHeader" data-megaContent-link="page-196"><button> Handling systems </button></li><li class="hasChildrenHeader" data-megaContent-link="page-195"><button> Inspection machines </button></li><li class="hasChildrenHeader" data-megaContent-link="page-194"><button> Packaging machines </button></li><li class="hasChildrenHeader" data-megaContent-link="page-193"><button> Packaging solutions </button></li><li><a href="/en/solutions/aseptic-processing"> Aseptic processing </a></li><li class="hasChildrenHeader" data-megaContent-link="page-191"><button> Consulting </button></li><li class="hasChildrenHeader" data-megaContent-link="page-205"><button> Services </button></li></ul></nav><div class="megaContent megaContentOpen megaAccordion-Content closeOnMobile" data-megaContent="page-189-overview"><header class="megaContentHeader hasChildrenHeader megaAccordionHeader-Content"><button> Overview </button><span class="plus small" /></header><section class="megaContentSection megaAccordionContent"><div class="textArea big megaDivider"><h3>Solutions</h3><div class="megaTeaserContent"><p>We have a solution for everything – and more importantly: they can all be connected through our unique Körber Ecosystem. In our current seven areas of expertise, we are at your disposal with our comprehensive know-how.</p><p><a href="/en/solutions" class="more">All Solutions</a></p></div></div></section></div><div class="megaContent"></div><div class="megaContent" data-megaContent="page-197"><header class="megaContentHeader hasChildrenHeader megaAccordionHeader-Content"><a href="/en/solutions/software">Software solutions</a><span class="plus small" /></header><section class="megaContentSection"><div class="textArea big megaDivider"><h3>Software solutions</h3><div class="megaTeaserContent"><p>With our PAS-X MES - on premise or cloud-based - and our software solutions for analysis, track & trace, networked factories, and intelligent packaging, we are the world's leading supplier and partner to the pharmaceutical and biotech industries. With our holistic understanding and use of digitalization, you remain future-proof and combine digital innovation with sustainability.</p><p><a href="/en/solutions/software" class="more">Overview Software solutions</a></p></div></div><div class="navigationArea siteLinkNavigation"><section class="slotsWrapper"><div class="slot"><nav><header class=""><a href="/en/solutions/software/pasx-extended">PAS-X: Much more than MES</a></header></nav><nav><header class=""><a href="/en/solutions/software/werum-pas-x-mes-suite">PAS-X MES Suite</a></header></nav><nav><header class=""><a href="/en/solutions/software/werum-pas-x-add-ons">Werum PAS-X Add-ons</a></header></nav><nav><header class=""><a href="/en/solutions/software/werum-pas-x-cell-gene-solution">Werum PAS-X Cell & Gene Solution</a></header></nav><nav><header class=""><a href="/en/solutions/software/regulatory-information-management">Regulatory information management (RIM)</a></header></nav></div><div class="slot"><nav><header class=""><a href="/en/solutions/software/werum-pas-x-as-a-service">Cloud-based: Werum PAS-X as a Service</a></header></nav><nav><header class=""><a href="/en/solutions/software/werum-pas-x-savvy">Werum PAS-X Savvy Suite</a></header></nav><nav><header class=""><a href="/en/solutions/software/werum-pas-x-content-suite">Werum PAS-X Content Suite</a></header></nav><nav><header class=""><a href="/en/solutions/software/pas-x-biopharma-solution">PAS-X Biopharma Solution</a></header></nav><nav><header class=""><a href="/en/solutions/digital">Digital solutions</a></header></nav></div></section></div><div class="teaserArea megaDivider"><div class="megaWrapper"><article class="teaser"><a href="/en/solutions/software/pasx-extended" class="imageContainer"><img title="PAS-X: Much more than MES" src="/fileadmin/_processed_/0/b/csm_Menu-Teaser-Werum-PAS-X-extended_f872e573e2.jpg" width="200" height="155" alt="" loading="lazy" /></a><div class="contentContainer"><h4><a href="/en/solutions/software/pasx-extended"> PAS-X: Much more than MES </a></h4><div class="megaTeaserContent"><p>PAS-X includes different suites such as MES Suite, Intelligence Suite, Content Suite, and Services Suite.</p><div class="link"><a href="/en/solutions/software/pasx-extended" class="more"> Read more </a></div></div></div></article></div></div></section></div><div class="megaContent" data-megaContent="page-196"><header class="megaContentHeader hasChildrenHeader megaAccordionHeader-Content"><a href="/en/solutions/handling">Handling systems</a><span class="plus small" /></header><section class="megaContentSection"><div class="textArea big megaDivider"><h3>Handling systems</h3><div class="megaTeaserContent"><p>Looking for perfectly designed production lines that reduce operational complexity, can adapt quickly to changes in the pharmaceutical industry and work seamlessly with your software and machinery? We are specialists for complete handling systems for pharmaceutical and medical products. Our solutions are decisive in the field of contactless and safe transport of e.g. glass syringes.</p><p><a href="/en/solutions/handling" class="more">Overview Handling systems</a></p></div></div><div class="navigationArea siteLinkNavigation"><section class="slotsWrapper"><div class="slot"><nav><header class=""><a href="/en/solutions/handling/transport-solutions">Transport solutions</a></header></nav><nav><header class=""><a href="/en/solutions/handling/contact-line-integration-handling">Line integration</a></header></nav><nav><header class=""><a href="/en/solutions/handling/customized-handling-systems">Customized handling solutions</a></header></nav></div><div class="slot"><nav><header class=""><a href="/en/solutions/handling/nest-and-tray-handling">Nest and tray handling</a></header></nav><nav><header class=""><a href="/en/solutions/handling/accumulation-solutions">Accumulation solutions</a></header></nav></div></section></div></section></div><div class="megaContent" data-megaContent="page-195"><header class="megaContentHeader hasChildrenHeader megaAccordionHeader-Content"><a href="/en/solutions/inspection">Inspection machines</a><span class="plus small" /></header><section class="megaContentSection"><div class="textArea big megaDivider"><h3>Inspection</h3><div class="megaTeaserContent"><p>As the world's leading inspection expert, we develop solutions for the pharmaceutical and biotech industries. Our range of products extends from AI-supported, high-performance machines and semi-automatic machines to laboratory units and inspection applications for in-process control. As thought leaders in the field, we always make sure that machines and software speak the same language.</p><p><a href="/en/solutions/inspection" class="more">Overview Inspection</a></p></div></div><div class="navigationArea siteLinkNavigation"><section class="slotsWrapper"><div class="slot"><nav><header class=""><a href="/en/solutions/inspection/machine-finder-inspection">Machine finder</a></header></nav><nav><header class=""><a href="/en/solutions/inspection/automatic-inspection">Automatic inspection</a></header></nav><nav><header class=""><a href="/en/solutions/inspection/semi-automatic-inspection-v90">Semi-automatic inspection</a></header></nav><nav><header class=""><a href="/en/solutions/refurbished-machinery">Refurbished Machines</a></header></nav></div><div class="slot"><nav><header class=""><a href="/en/solutions/inspection/in-process-control">In-process control</a></header></nav><nav><header class=""><a href="/en/solutions/inspection/lab-equipment">Lab equipment</a></header></nav><nav><header class=""><a href="/en/solutions/inspection/contact-line-integration-inspection-1">Line integration</a></header></nav></div></section></div><div class="teaserArea megaDivider"><h3>Machine finder</h3><div class="megaWrapper"><article class="teaser"><a href="/en/solutions/inspection/machine-finder-inspection" class="imageContainer"><img title="Go directly to our machines" src="/fileadmin/_processed_/f/0/csm_01_Solutions_Inspection_f98c47e9da.jpg" width="200" height="156" alt="" loading="lazy" /></a><div class="contentContainer"><h4><a href="/en/solutions/inspection/machine-finder-inspection"> Go directly to our machines </a></h4><div class="megaTeaserContent"><p>Filter according to the criteria you are concerned about.</p><div class="link"><a href="/en/solutions/inspection/machine-finder-inspection" class="more"> Read more </a></div></div></div></article></div></div><div class="teaserArea megaDivider"><div class="megaWrapper"><article class="teaser"><a href="/en/services/xpert-view" class="imageContainer"><img title="Remote Service Tool Körber Xpert View" src="/fileadmin/_processed_/a/1/csm_xpert-view-teaser_a37042dbcc.jpg" width="200" height="156" alt="" loading="lazy" /></a><div class="contentContainer"><h4><a href="/en/services/xpert-view"> Remote Service Tool Körber Xpert View </a></h4><div class="megaTeaserContent"><p>Support whenever and whereever you need it. Reduce your downtime and improve your production quality with Körber Xpert View.</p><div class="link"><a href="/en/services/xpert-view" class="more"> Read more </a></div></div></div></article></div></div></section></div><div class="megaContent" data-megaContent="page-194"><header class="megaContentHeader hasChildrenHeader megaAccordionHeader-Content"><a href="/en/solutions/packaging-machines">Packaging machines</a><span class="plus small" /></header><section class="megaContentSection"><div class="textArea big megaDivider"><h3>Packaging machines</h3><div class="megaTeaserContent"><p>We are a leading supplier of packaging machines for liquid and solid pharmaceutical and medical products. With our blister, sachet and stick packaging machines we offer solutions for primary packaging. Our side and topload cartoners set standards worldwide for secondary packaging. Our ecosystem approach ensures that all machines, software, and other components operate harmoniously and perform at the highest level.</p><p><a href="/en/solutions/packaging-machines" class="more">Overview Packaging machines</a></p></div></div><div class="navigationArea siteLinkNavigation"><section class="slotsWrapper"><div class="slot"><nav><header class=""><a href="/en/solutions/packaging-machines/blister">Blister lines</a></header></nav><nav><header class=""><a href="/en/solutions/packaging-machines/contact-line-integration">Line integration</a></header></nav><nav><header class=""><a href="/en/solutions/refurbished-machinery">Refurbished machines</a></header></nav></div><div class="slot"><nav><header class=""><a href="/en/solutions/packaging-machines/cartoner">Cartoner</a></header></nav><nav><header class=""><a href="/en/solutions/packaging-machines/sachets-stick-packs">Sachet and stick pack packaging</a></header></nav><nav><header class=""><a href="/en/solutions/packaging-machines/end-of-line-solutions">End of Line solutions</a></header></nav></div></section></div><div class="teaserArea megaDivider"><div class="megaWrapper"><article class="teaser"><a href="/en/solutions/packaging-machines/end-of-line-solutions/topload-case-packer" class="imageContainer"><img title="K.Pak Topload Case Packer" src="/fileadmin/_processed_/1/b/csm_Header-Packagaging-Machines-End-of-Line_3dfdacbd05.png" width="200" height="199" alt="" loading="lazy" /></a><div class="contentContainer"><h4><a href="/en/solutions/packaging-machines/end-of-line-solutions/topload-case-packer"> K.Pak Topload Case Packer </a></h4><div class="megaTeaserContent"><p>Introducing our latest solution from Körber; the K.Pak Topload Case Packer! Created specifically for the pharmaceutical industry, the K.Pak solution provides operator-friendly machines to complete any production line. Our solution focuses on innovative technology, high-quality design and expert handling and packaging of your product. It’s time to start connecting the dots with Körber!</p><div class="link"><a href="/en/solutions/packaging-machines/end-of-line-solutions/topload-case-packer" class="more"> Read more </a></div></div></div></article></div></div></section></div><div class="megaContent" data-megaContent="page-193"><header class="megaContentHeader hasChildrenHeader megaAccordionHeader-Content"><a href="/en/solutions/packaging-materials">Packaging solutions</a><span class="plus small" /></header><section class="megaContentSection"><div class="textArea big megaDivider"><h3>Packaging solutions</h3><div class="megaTeaserContent"><p>As long-standing specialists, we develop packaging solutions for innovative and high-quality secondary pharmaceutical packaging made of cardboard. We offer you solutions for counterfeit protection, standard folding boxes and much more.</p><p><a href="/en/solutions/packaging-materials" class="more">Overview Packaging solutions</a></p></div></div><div class="navigationArea siteLinkNavigation"><section class="slotsWrapper"><div class="slot"><nav><header class=""><a href="/en/solutions/packaging-materials/sustainable-packaging">Sustainable packaging</a></header></nav><nav><header class=""><a href="/en/solutions/packaging-materials/smart-packaging">Smart packaging</a></header></nav><nav><header class=""><a href="/en/solutions/packaging-materials/folding-boxes">Folding boxes</a></header></nav><nav><header class=""><a href="/en/solutions/packaging-materials/wallet-packaging">Wallet packaging</a></header></nav></div><div class="slot"><nav><header class=""><a href="/en/solutions/packaging-materials/packaging-erecting-service">Packaging erecting service</a></header></nav><nav><header class=""><a href="/en/solutions/packaging-materials/clinical-trials">Packaging for clinical trials</a></header></nav><nav><header class=""><a href="/en/solutions/packaging-materials#c1777">Safe packaging</a></header></nav></div></section></div><div class="teaserArea megaDivider"><div class="megaWrapper"><article class="teaser"><a href="/en/blog/how-the-packaging-qualification-service-supports-manufacturers-to-accelerate-product-launches" class="imageContainer"><img title="From development to market readiness" src="/fileadmin/_processed_/4/2/csm_PQS_MB_2_9109faa7ff.jpg" width="200" height="156" alt="" loading="lazy" /></a><div class="contentContainer"><h4><a href="/en/blog/how-the-packaging-qualification-service-supports-manufacturers-to-accelerate-product-launches"> From development to market readiness </a></h4><div class="megaTeaserContent"><p>Körber offers Packaging Qualification Services from a single source.</p><div class="link"><a href="/en/blog/how-the-packaging-qualification-service-supports-manufacturers-to-accelerate-product-launches" class="more"> Read more </a></div></div></div></article><article class="teaser"><a href="/en/solutions/packaging-materials/growth-in-the-pharmaceutical-packaging-business-koerber-expands-its-capacity" class="imageContainer"><img title="Expansion of production capacities in the packaging sector" src="/fileadmin/_processed_/c/5/csm__MGL9933_30_20_300_TE_0a254ebe02.jpg" width="200" height="156" alt="" loading="lazy" /></a><div class="contentContainer"><h4><a href="/en/solutions/packaging-materials/growth-in-the-pharmaceutical-packaging-business-koerber-expands-its-capacity"> Expansion of production capacities in the packaging sector </a></h4><div class="megaTeaserContent"><p>Körber increases its secondary packaging capacities to meet rising demand and ensure security of supply.</p><div class="link"><a href="/en/solutions/packaging-materials/growth-in-the-pharmaceutical-packaging-business-koerber-expands-its-capacity" class="more"> Read more </a></div></div></div></article></div></div></section></div><div class="megaContent"><header class="megaContentHeader "><a href="/en/solutions/aseptic-processing">Aseptic processing</a></header></div><div class="megaContent" data-megaContent="page-191"><header class="megaContentHeader hasChildrenHeader megaAccordionHeader-Content"><a href="/en/solutions/consulting">Consulting</a><span class="plus small" /></header><section class="megaContentSection"><div class="textArea big megaDivider"><h3>Consulting</h3><div class="megaTeaserContent"><p>Our experts will advise you during the analysis of your requirements, show you optimization potential and support you during the implementation of projects in all areas of the pharmaceutical, biotech and medical device industry. Our aim is to achieve holistic optimization for your factory of excellence.</p><p><a href="/en/solutions/consulting" class="more">Overview Consulting</a></p></div></div><div class="navigationArea siteLinkNavigation"><section class="slotsWrapper"><div class="slot"><nav><header class=""><a href="/en/solutions/consulting#c1804">Manufacturing execution system consulting</a></header></nav><nav><header class=""><a href="/en/solutions/consulting/digitalconsulting">Digital Transformation consulting</a></header></nav><nav><header class=""><a href="/en/solutions/consulting#c1802">Manufacturing operations management consulting</a></header></nav><nav><header class=""><a href="/en/solutions/consulting/supply-chain-management-consulting">Supply chain management consulting</a></header></nav></div><div class="slot"><nav><header class=""><a href="/en/solutions/consulting#c1803">Computerized System Validation (CSV) consulting</a></header></nav><nav><header class=""><a href="/en/solutions/digital/lineoptimizer">Line-Optimization</a></header></nav><nav><header class=""><a href="/en/solutions/consulting/track-trace-consulting">Track & Trace consulting</a></header></nav><nav><header class=""><a href="/en/services/pas-x-cmc-innovation-consulting">PAS-X CMC Innovation Consulting</a></header></nav></div></section></div><div class="teaserArea megaDivider"><div class="megaWrapper"></div></div><div class="teaserArea megaDivider"><div class="megaWrapper"></div></div></section></div><div class="megaContent" data-megaContent="page-205"><header class="megaContentHeader hasChildrenHeader megaAccordionHeader-Content"><a href="/en/services">Services</a><span class="plus small" /></header><section class="megaContentSection"><div class="textArea big megaDivider"><h3>Services</h3><div class="megaTeaserContent"><p>You need help with a specific product or have questions about one of our areas of expertise? Körber is your forward-looking navigator to excellence. 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Use our unique combination of process knowledge and data science expertise to reduce time-to-market and consistently improve process performance and robustness.</p><p>At Körber, we blend biotechnological process expertise with cutting-edge data analysis techniques. With over 10 years of hands-on experience, we deploy data science tools across the entire process lifecycle – from characterization and performance qualification to continued process verification and real-time control. Our track record includes successfully supporting the commercialization of 20+ pharmaceutical products. Applying statistical best practices, advanced modelling approaches, and end-to-end modelling, coupled with our expert knowledge, we help you optimize, validate, and control your processes efficiently. This approach enhances product quality, boosts productivity, and provides a robust foundation for discussions with regulatory authorities (FDA, EMA, etc.).</p><p>Together, we ensure reliable process characterizations, rapid technology transfers, compliant process validation campaigns and robust process control.</p></div></section></div></div><a class="anchor" id="c21552"></a><a class="anchor" id="c21553"></a><div id="t21552" ><section id="c21552" class="quote spacing-t-m"><figure class="side-image "><div class="image-container"><img src="/fileadmin/_processed_/9/8/csm_BI_logo_1x1_755f7f16c7.png" width="200" height="200" alt="" loading="lazy" /></div></figure><blockquote><p class="quote-small"><span class="quotemarks">l</span><span>Körber Pharma Austria GmbH successfully helped Boehringer Ingelheim RCV in their Process Characterization Study using innovative End-to-End process models. This led to an efficient and scientifically sound establishment of a control strategy including specification driven in-process-control limits for CQAs and CPP.</span><span class="quotemarks">r</span></p><p class="copy-xs">Boehringer Ingelheim Research Center Vienna</p></blockquote></section></div><a class="anchor" id="c20822"></a><a class="anchor" id="c20823"></a><div id="t20822" ><section id="c20822" class="quote spacing-t-m"><figure class="side-image round"><div class="image-container"><img src="/fileadmin/_processed_/f/0/csm_TZa_I_c5178efeb5.jpg" width="200" height="200" alt="" loading="lazy" /></div></figure><blockquote><p class="quote-small"><span class="quotemarks">l</span><span>We accelerate your process commercialization and increase your productivity! Benefit from our 10 years of experiences at the interface between data analytics and process knowledge</span><span class="quotemarks">r</span></p><p class="copy-xs">Dr. Thomas Zahel, Head of CMC Innovation Consulting, Körber Business Area Pharma</p></blockquote></section></div><a class="anchor" id="c20825"></a><a class="anchor" id="c20826"></a><div id="t20825" ><div class="spacing-t-m"><section class="content"><div class="outer copy-md"><p><a href="mailto:thomas.zahel@koerber.com" class="btn">Contact our Head of CMC Innovation Consulting</a></p></div></section></div></div><a class="anchor" id="c21298"></a><a class="anchor" id="c21299"></a><div id="t21298" ><section class="accordions spacing-t-m"><div class="sectionHead"></div><button class="accordion"><h2 class="btnHeadline order-5"> Process Characterization (Process validation stage 1) </h2><span class="plus"></span></button><div class="panel"><div class="text"><p><strong>Process validation consists of three stages that are interlinked to each other.</strong></p><p>The first one, <a href="/en/blog/what-is-process-characterization" class="underline">Process Characterization</a>, is the most essential step to establish a <a href="/en/blog/the-biggest-flaws-in-setting-a-control-strategy-in-biopharmaceutical-manufacturing" class="underline">Control Strategy</a> in accordance with FDA, EMA and ICH guidelines, ensuring consistent product quality. To achieve this activity, the relationship between process inputs (process parameters, material attributes) and the process output (critical quality attributes, product amount) needs to be understood and controlled. This relationship can be learned from data and prior knowledge.</p><p><strong>Our unique workflow guides you through this critical phase, comprising:</strong></p><ol><li>Risk assessment</li><li>Scale down model establishment and comparison</li><li>Experimental design (for statistical and dynamic models)</li><li>Experimental analysis and criticality assessment (linear regression models, linear mixed models including random effects, dynamic models for up- and downstream)</li><li>Setting a holistic control strategy using the end-to-end process modelling framework</li></ol><p><strong>With over a decade of experience and involvement in more than 20 product commercialization,</strong> we've fostered productive exchanges with regulatory authorities and have gained expertise across diverse product areas like monoclonal antibodies, recombinant protein, pDNA, and more.</p><p>We have published over 10 peer reviewed papers with large pharmaceutical companies like Boehringer Ingelheim and Takeda that demonstrate the effectiveness of our approach. In a <a href="/en/blog/how-to-reduce-time-to-market-by-50-percent" class="underline">recent peer-reviewed scientific publication</a>, we demonstrated that our method results in a reduction of over 50% in the number of experiments required by leveraging self-learning digital shadows. This method was also demonstrated at many conferences like the <a href="https://virtual.ispe.org/sessions/9281/view" target="_blank" class="underline" rel="noreferrer">2023 ISPE Biotechnology conference</a>. </p><p><strong>We support you with:</strong></p><ul><li>Faster time-to-market by reducing number of experiments by >50%</li><li>Regulatory accepted workflows and risk assessments according to ICH Q9 / ICH Q12</li><li>Holistic control strategies leading along ICH Q8 to widest possible PARs and design spaces</li><li>Data based criticality assessment of process parameters</li><li>Timely delivery of results</li></ul></div></div><button class="accordion"><h2 class="btnHeadline order-5"> Process Performance Qualification (Process validation stage 2) </h2><span class="plus"></span></button><div class="panel"><div class="text"><p>In the second step, we consult you in determining the number of runs needed for a (Process Performance Qualification (PPQ) campaign.</p><p><strong>We support you with:</strong></p><ul><li>Drafting a PPQ protocol</li><li>Statistical determination of number of PPQ runs</li><li>PPQ execution</li></ul></div></div><button class="accordion"><h2 class="btnHeadline order-5"> CPV in manufacturing (Process validation stage 3) </h2><span class="plus"></span></button><div class="panel"><div class="text"><p><a href="/en/blog/successfully-managing-your-bioprocess-the-importance-of-continued-process-verification" class="underline">Continued process verification</a> (CPV) is the third step of the process validation life cycle and ensures that the process is in state of control during commercial manufacturing. Within a CPV plan, it is specified which CQAs (Critical Quality Attributes) and which CPPs (Critical Process Parameters) are monitored on a regular basis. The plan also defines which trending rules and control limits will be used, how often sampling must be performed, and how to invest and communicate when trend violations occur.</p><p><strong>In general, the establishment of the CPV plan can be divided into two phases:</strong></p><ol><li>Initial CPV Plan <ol><li>Number of available data is too small for statistical application</li><li>Process knowledge in manufacturing is too low for reduction sampling frequency</li><li>List of monitoring CPPs and even CQAs are at maximum</li></ol></li><li>Full CPV Plan <ol><li>Data is sufficient for statistical application</li><li>Process knowledge increases</li><li>Sampling frequency can be reduced and number of CQA and CPPs can be decreased</li></ol></li></ol><p>We have strong expert knowledge in this area and can facilitate the creation of an efficient and goal oriented CPV plan creation or update of your process.</p><p><strong>We support you with:</strong></p><ul><li>Definition of methods for trending</li><li>Selection of CPPs and CQAs for monitoring</li><li>Calculation of control limits</li><li>Support to iteratively reduce the sampling plan</li></ul></div></div><button class="accordion"><h2 class="btnHeadline order-5"> Hybrid Modelling for USP and DSP </h2><span class="plus"></span></button><div class="panel"><div class="text"><p>Most of the process steps in biopharmaceutical manufacturing have a time dynamic behavior. Instead of looking at the end values, e.g., end of fermentation or end pool value of chromatography, we can make use of measurements on the time evolution of critical quality attributes, metabolites, and product amount.</p><p>First principles, like mass balances or diffusion phenomena, can be combined with data-driven models that describe reaction mechanisms or binding isotherms. </p><p><strong>This methodology brings benefits along the entire process life cycle:</strong></p><ul><li>Process Development for faster optimization</li><li>Process Characterization for reduction of the number of experiments</li><li>CPV for reduction of false alarms</li></ul><p>With this, we can generate generalizable process knowledge across scales and products and establish a process knowledge platform that enables fast time to market and reduction of cost of goods in manufacturing via real-time control.</p><p><strong>We support you with:</strong></p><ul><li>Establishment of time dynamic models for USP and DSP</li><li>Experimental design to reduce number of experiments</li><li>Offline application to optimize the process performance and set up ICH Q8 relevant control strategies</li><li>Real time application to control the process in closed loop</li></ul></div></div><button class="accordion"><h2 class="btnHeadline order-5"> Biosimilarity & Comparability </h2><span class="plus"></span></button><div class="panel"><div class="text"><p>Biosimilars have emerged as affordable alternatives to approved biologic drugs, meeting the industry's growing demand for cost-effective treatment options. These medicines provide effective and safe therapies while reducing the financial burden on patients and healthcare systems. </p><p>The critical question in this area is: How can we achieve and prove that a biosimilar is similar enough? We have worked for years to develop <a href="https://link.springer.com/article/10.1208/s12248-022-00749-3" target="_blank" class="underline" rel="noreferrer">new statistical methods</a> that enable biosimilar manufacturers to develop a manufacturing process that results in biosimilars that pass the bioequivalence test. For that we have developed a clear workflow that follows a systematic way of experimental design and analysis to establish a control strategy that ensures chances of passing the final analytical biosimilarity assessment and getting drug approval. </p><p>Adopting a <a href="/en/blog/how-to-test-regulatory-compliantly-for-analytical-biosimilarity-and-reduce-business-risk-and-time-to-market" class="underline">regulatory compliant analytical bootstrapping test</a> that controls the Type I error enables companies to establish analytical similarity, leading to faster market entry with a 10 percent higher acceptance rate.</p><p><strong>We support you with:</strong></p><ul><li>A systematic approach to ensure analytical biosimilarity </li><li>Circumventing flawed x-SD approaches and other simple range tests that are questioned in recent regulatory expectations</li><li>Using the correct, scientifically sound, and regulatory accepted analytical biosimilarity test</li><li>Maximizing the chances of drug approval</li></ul></div></div><button class="accordion"><h2 class="btnHeadline order-5"> Digital shadows as recommender systems for manufacturing </h2><span class="plus"></span></button><div class="panel"><div class="text"><p>Digital shadows and <a href="/en/blog/what-is-a-bioprocess-digital-twin" class="underline">digital twins</a> come into play during process development and process validation, but can reach their full potential during reoccurring manufacturing. This is where we use our unique and <a href="https://service.koerber-pharma.com/en/sof_0069_pas-x-savvy_factsheet_fl" target="_blank" class="underline" rel="noreferrer">innovative end-to-end process models</a> to predict the impact of deviations and help to manage and justify them faster. This is a digital shadow application as it does not connect or control the process in real time. However, it has huge benefits as it saves costly investigations and CAPAs. </p><p><strong>We support you with:</strong></p><ul><li>Establishment of end-to-end digital shadows from process development and manufacturing data</li><li>Validation and verification of end-to-end process models along regulatory guidelines and V&V40 standards</li></ul></div></div><button class="accordion"><h2 class="btnHeadline order-5"> Real-time control using end-to-end digital twins </h2><span class="plus"></span></button><div class="panel"><div class="text"><p>Numerous FDA and EMA initiatives advocate automatic real-time control, transitioning away from quality-by-testing to <a href="/en/blog/a-new-quality-by-design-qbd-approach-in-early-bioprocess-development" class="underline">Quality by Design (QbD)</a>.</p><p>Our unique and innovative <a href="https://service.koerber-pharma.com/en/sof_0069_pas-x-savvy_factsheet_fl" target="_blank" class="underline" rel="noreferrer">end-to-end process models</a> can be used as prescriptive analytics that work like Google Maps. If you deviate from the optimal path in manufacturing (e.g., deviation in process parameters), it acts as recommender system to guide you back on track. </p><p>It predicts optimal changes to the rest of the manufacturing process across multiple process steps to reduce the likelihood of process failures due to quality issues and increases the total yield of the process. This results in a substantial reduction in the cost of goods by more than 20% and provides a recurring revenue stream for our customers.</p><p>The <a href="/en/solutions/software/werum-pas-x-savvy" class="underline">PAS-X Savvy</a> digital twin connects with the <a href="/en/solutions/software/werum-pas-x-mes-suite" class="underline">PAS-X MES</a> system to provide a unique capability to control, monitor and document the process changes introduced.</p><p><strong>We support you with:</strong></p><ul><li>Establishment of end-to-end digital twins from process development and manufacturing data</li><li>Validation and verification of end-to-end process models along regulatory guidelines and V&V40 standards</li><li>Connection of end-to-end process digital twins to middleware, SCADA, QMS and MES systems</li></ul></div></div></section></div><a class="anchor" id="c21301"></a><a class="anchor" id="c21302"></a><div id="t21301" ><section class="gallery spacing-t-m" data-autoplay="false"><div class="thumbs"><a href="/fileadmin/user_upload/Services/pas-x-cmc/CMC_Figure_1-3.png" class="thumb"><figure class=""><div class="image-container"><img src="/fileadmin/_processed_/9/f/csm_CMC_Figure_1-3_4fd8502427.png" width="1140" height="642" alt="" loading="lazy" /></div><figcaption class=" copy-xs"> End-to-end process models make it possible to predict the quality of the end product to determine control strategies (Proven Acceptable Range (PAR), and design spaces) with large operational flexibility and holistic criticality. </figcaption></figure></a><a href="/fileadmin/user_upload/Services/pas-x-cmc/CMC_Figure_1-2.png" class="thumb"><figure class=""><div class="image-container"><img src="/fileadmin/_processed_/8/c/csm_CMC_Figure_1-2_2a60a96b88.png" width="1140" height="642" alt="" loading="lazy" /></div><figcaption class=" copy-xs"> End-to-end process models make it possible to predict the quality of the end product to determine control strategies (Proven Acceptable Range (PAR), and design spaces) with large operational flexibility and holistic criticality. </figcaption></figure></a><a href="/fileadmin/user_upload/Services/pas-x-cmc/Figure_2.png" class="thumb"><figure class=""><div class="image-container"><img src="/fileadmin/_processed_/9/a/csm_Figure_2_2e62b49dcb.png" width="1140" height="642" alt="" loading="lazy" /></div><figcaption class=" copy-xs"> Key to successful CPV is the right CPV plan, followed by lean and transparent execution. End-to-end process models empower to differentiate between normal and special cause variation </figcaption></figure></a><a href="/fileadmin/user_upload/Services/pas-x-cmc/CMC_Figure_3.png" class="thumb"><figure class=""><div class="image-container"><img src="/fileadmin/_processed_/3/5/csm_CMC_Figure_3_2110952117.png" width="1140" height="642" alt="" loading="lazy" /></div><figcaption class=" copy-xs"> Hybrid and mechanistic models for (A) fermentation and (B) chromatography processes. </figcaption></figure></a><a href="/fileadmin/user_upload/Services/pas-x-cmc/Figure_4.png" class="thumb"><figure class=""><div class="image-container"><img src="/fileadmin/_processed_/4/b/csm_Figure_4_dd4fd470b7.png" width="1140" height="642" alt="" loading="lazy" /></div><figcaption class=" copy-xs"> By adopting our bootstrapping test, you can confidently establish the analytical similarity of your biosimilar product and hence safe costly clinical trials. </figcaption></figure></a><a href="/fileadmin/user_upload/Services/pas-x-cmc/Figure_5.png" class="thumb"><figure class=""><div class="image-container"><img src="/fileadmin/_processed_/2/6/csm_Figure_5_e38d1553c9.png" width="1140" height="642" alt="" loading="lazy" /></div><figcaption class=" copy-xs"> End-to-end process models can act as digital shadows during manufacturing execution in predicting the impact of a deviation onto product quality and amount. </figcaption></figure></a><a href="/fileadmin/user_upload/Services/pas-x-cmc/Figure_6.png" class="thumb"><figure class=""><div class="image-container"><img src="/fileadmin/_processed_/b/a/csm_Figure_6_61e20b510d.png" width="1140" height="642" alt="" loading="lazy" /></div><figcaption class=" copy-xs"> A recommender system using end-to-end process models enables to increase overall yield and product quality by >10%. Recommendations are displayed and can be automatically or manually accepted after documentation. Automatic interfaces to the shopfloor (MES, SCADA) allow seamless data transfer from the process and writing of new setpoints into the MES system for subsequent execution. </figcaption></figure></a></div></section></div><a class="anchor" id="c20831"></a><a class="anchor" id="c20832"></a><div id="t20831" ><section class="downloads spacing-t-m"><div class="download"><h4 class="copy-md bold">Brochure: PAS-X CMC Innovation Consulting</h4><div class="image-container"><img src="/fileadmin/_processed_/0/d/csm_cov_Koerber_sof_0095_PAS-X_CMC_Innov_Consulting_FS_EN_v03_f5c816cfdd.jpg" width="420" height="236" alt="" loading="lazy" /></div><p>Our experts leverage best-in-class Data Science tools to optimize your entire process lifecycle, from process development to manufacturing.</p><p class="copy-sm"><a href="https://service.koerber-pharma.com/en/sof_0095_pas-x_cmc_innov_consulting_fs_en" class="download-link" target="_blank"> Download </a></p></div><div class="download"><h4 class="copy-md bold">Factsheet: Integrated process modelling with Werum PAS-X Savvy</h4><div class="image-container"><img src="/fileadmin/_processed_/9/6/csm_69_pas-x-savvy_factsheet_fl_EN_c9aa47679b.jpg" width="420" height="236" alt="" loading="lazy" /></div><p>With its breakthrough innovation Process Models (PMs), Werum PAS-X Savvy enables a holistic control strategy, deviation management and batch release in real time</p><p class="copy-sm"><a href="https://service.koerber-pharma.com/en/sof_0069_pas-x-savvy_factsheet_fl" class="download-link" target="_blank"> Download </a></p></div></section></div><section style="background-color: rgb(245,243,241)" class="content-element ce-grid default spacing-t-m grid-color columns3"><a class="link-to-element" id="c10737"></a><a class="link-to-element" id="c10744"></a><div class="container"><h3 class="order-3"> Your benefits </h3><div class="row justify-content-center align-items-start"><div class="col-12 col-sm-6 col-lg-4"><a class="anchor" id="c10738"></a><a class="anchor" id="c10743"></a><div id="t10738" ><h3 class="copy-md bold"><img class="grid-icon" src="/fileadmin/user_upload/Solutions/Software/2_speed-black-18dp.svg" width="36" height="36" alt="" /> Faster Time-to-Market </h3><div class="textbox"><ul><li>Rapid approval and validation of manufacturing processes according to regulatory requirements</li><li>Reducing number of experiments by more than 50% to obtain sufficient process knowledge</li></ul></div></div></div><div class="col-12 col-sm-6 col-lg-4"><a class="anchor" id="c10739"></a><a class="anchor" id="c10742"></a><div id="t10739" ><h3 class="copy-md bold"><img class="grid-icon" src="/fileadmin/user_upload/Solutions/Software/trending_up-black-18dp.svg" width="36" height="36" alt="" /> Higher success rate </h3><div class="textbox"><ul><li>Faster reliable and mathematically sound results thanks to our statistical reporting</li><li>Increased success rate of meeting specifications in manufacturing using holistic control strategies and digital twins</li></ul></div></div></div><div class="col-12 col-sm-6 col-lg-4"><a class="anchor" id="c10740"></a><a class="anchor" id="c10741"></a><div id="t10740" ><h3 class="copy-md bold"><img class="grid-icon" src="/fileadmin/user_upload/Solutions/Software/thumb_up-black-18dp.svg" width="36" height="36" alt="" /> Real added value </h3><div class="textbox"><ul><li>Identifying potential and increasing productivity with the right data</li><li>Lowering costs of goods by more than 20% and establishing a reoccurring revenue stream for our clients</li></ul></div></div></div></div></div></section><section class="content-element ce-grid default spacing-t-m bg-transparent columns3"><a class="link-to-element" id="c20834"></a><a class="link-to-element" id="c20835"></a><div class="container"><div class="row justify-content-center align-items-start"><div class="col-12 col-sm-6 col-lg-4"><a class="anchor" id="c20837"></a><a class="anchor" id="c20838"></a><div id="t20837" ><img src="/fileadmin/_processed_/0/b/csm_Header-Pharma-Software-How-to-perform-successful-process-characterization_8dc36218d5.jpg" width="1200" height="676" alt="" loading="lazy" /><h3 class="copy-md bold"> Successful process characterization in biotech </h3><div class="textbox"><p>A how-to-guide in 7 steps for faster time-to-market </p><p><a href="/en/blog/pharma-software-how-to-perform-successful-process-characterization" class="btn">Read the blog article</a></p></div></div></div><div class="col-12 col-sm-6 col-lg-4"><a class="anchor" id="c20840"></a><a class="anchor" id="c20841"></a><div id="t20840" ><img src="/fileadmin/_processed_/9/7/csm_BLOGPOST_IMAGES_Header_5b5fc132e8.png" width="1200" height="675" alt="" loading="lazy" /><h3 class="copy-md bold"> Analytical biosimilarity </h3><div class="textbox"><p>How to test regulatory compliantly for analytical biosimilarity and reduce business risk</p><p><a href="/en/blog/how-to-test-regulatory-compliantly-for-analytical-biosimilarity-and-reduce-business-risk-and-time-to-market" class="btn">Read the blog article</a></p></div></div></div><div class="col-12 col-sm-6 col-lg-4"><a class="anchor" id="c20843"></a><a class="anchor" id="c20844"></a><div id="t20843" ><img src="/fileadmin/_processed_/5/c/csm_Header_695c99a0f0.jpg" width="1200" height="675" alt="" loading="lazy" /><h3 class="copy-md bold"> End-to-end digital twin </h3><div class="textbox"><p>How a self-learning digital twin enables the reduction of experiments in PCS by more than 50%</p><p><a href="/en/blog/how-to-reduce-time-to-market-by-50-percent" class="btn">Read the blog article</a></p></div></div></div></div></div></section><a class="anchor" id="c11858"></a><a class="anchor" id="c11859"></a><div id="t11858" ><section class="teasers full-width-teasers spacing-t-m"><div class="row image-text" style="background-color:rgb(0,96,255)"><div class="col-12 col-md-6 col-lg-7"><img src="/fileadmin/_processed_/e/4/csm_1_AdobeStock_240748870_bearbeitet_PAS-X_Savvy_b65e3fb3ae.jpg" width="690" height="389" alt="" loading="lazy" /></div><div class="col-12 col-md-6 col-lg-5"><div class="textbox copy-md white"><h2 class="order-3"> Werum PAS-X Savvy </h2><p>Werum PAS-X Savvy from Körber combines the management, visualization, and analysis of data from a variety of sources using automated reports of the findings in an intuitive software environment. This way, you can accelerate pharmaceutical and biopharmaceutical product development, ensure product commercialization, and optimize productivity.</p><p><a href="/en/solutions/software/werum-pas-x-savvy" class="btn">Find out more</a></p></div></div></div></section></div><a class="anchor" id="c10745"></a><a class="anchor" id="c10746"></a><a class="anchor" id="c1595"></a><a class="anchor" id="c3876"></a><div id="t1595" ><section class="teasers full-width-teasers spacing-t-m"><div class="row image-text" style="background-color:rgb(0,96,255)"><div class="col-12 col-md-6 col-lg-7"><div class="svg-image"data-width="690"><object data="/fileadmin/user_upload/Miscellaneous/PHARMA_Kontakt-Illustration.svg" ></object></div></div><div class="col-12 col-md-6 col-lg-5"><div class="textbox copy-md white"><h2 class="order-1"> Any questions? </h2><p>Get in contact with us. 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