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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="">Packaging development</a></header></nav><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="">Clinical trials</a></header></nav><nav><header class=""><a href="/en/solutions/packaging-materials/marketing-collateral-services">Marketing collateral Services</a></header></nav></div><div class="slot"><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#c1777">Safe packaging</a></header></nav><nav><header class=""><a href="/en/solutions/packaging-materials/wallet-packaging">Wallet packaging</a></header></nav><nav><header class=""><a href="/en/solutions/packaging-materials/packaging-erecting-service">Packaging erecting service</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></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. 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</h1></section></div></div><section class="cover"><div class="image-container"><picture><source media="(max-width: 767px)" srcset="/fileadmin/_processed_/f/f/csm_FDA-Guidance-for-Industry_7aba8a659a.png"><img src="/fileadmin/_processed_/f/f/csm_FDA-Guidance-for-Industry_9bfe37d2a9.png" width="712" height="401" alt="" loading="lazy" /></picture><div class="caption"></div></div></section><a class="anchor" id="c16513"></a><a class="anchor" id="c16668"></a><div id="t16513" ><div class="spacing-t-m"><section class="content"><div class="outer copy-md"><h3 class="order-5">Highlights</h3><ul><li>What is process characterization for biological drugs?;</li><li>Which regulatory guidance is available?;</li><li>Goals & timing within the product lifecycle?</li><li>Role of data management & statistics in process characterization studies;</li></ul><p>Process characterization is an essential step in the commercialization of a new (biological-) drug. For drug product commercialization, manufacturers must validate the drug’s manufacturing process. This ensures that the manufacturing process delivers a quality product consistently and that the patient is not at risk.</p></div></section></div></div><a class="anchor" id="c16514"></a><a class="anchor" id="c16669"></a><div id="t16514" ><div class="spacing-t-m"><section class="content"><div class="outer copy-md"><p><em>"Process Validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality product <a href="https://www.fda.gov/media/71021/download" target="_blank" rel="noreferrer">FDA process validation guideline</a>"</em></p><p>If you want to learn how to perform a successful process characterization study and what steps need to be taken, visit this <a href="/en/blog/pharma-software-how-to-perform-successful-process-characterization">blog post</a>.</p><p>Recently, US and European regulators have issued new process validation guidelines. The new guidelines now emphasize:</p><ul><li>the demonstration of process understanding;</li><li>risk-based identification of critical process parameters;</li><li>implementation of well-validated control strategies.</li></ul><p>As a result of the new guidelines, it is now the state of the art that drug manufacturers thoroughly investigate and <strong>“characterize”</strong> the manufacturing processes. Interestingly, the term <strong>“process characterization”</strong> is not used by the regulators. Therefore, you will not find it in the EMAs and FDAs process validation guidelines. Yet, CMOs and (bio-) pharmaceutical companies use the term “process characterization” to describe their activities related to stage 1 process validation.</p><p>“Process characterization is how industry puts stage 1 process validation into practice.”</p></div></section></div></div><a class="anchor" id="c16515"></a><a class="anchor" id="c16670"></a><div id="t16515" ><section class="content-image ratio-16-9 spacing-t-m"><figure class=""><div class="image-container"><img src="/fileadmin/_processed_/f/f/csm_FDA-Guidance-for-Industry_7c9ea0f41f.png" width="712" height="401" alt="" loading="lazy" /></div></figure></section></div><a class="anchor" id="c16516"></a><a class="anchor" id="c16671"></a><div id="t16516" ><div class="spacing-t-m"><section class="content"><div class="outer copy-md"><h2 class="order-5">Why do manufacturers run process characterization studies? </h2><p><em>Reason 1: Achieve compliance.</em> Ultimately, the product should reach the patient. To achieve this, manufacturers must validate the manufacturing process. Process characterization is an integral part of stage 1 process validation. </p><p><em>Reason 2: Avoid registration delays.</em> A delay in the commercialization of a product negatively impacts patients: They have no access to a drug they can benefit from. Furthermore, a delay in the commercialization costs money:</p><p>Costly registration delays resulting from poorly understood processes and failed validation batches can cost a company tens of millions of dollars James E. Seely, Ph.D., Robert J. Seely <a href="http://www.biopharminternational.com/rational-step-wise-approach-process-characterization" target="_blank" rel="noreferrer">A Rational, Step-Wise Approach to Process Characterization</a></p><p><em>Reason 3: Avoid failed batches.</em> Failed commercial batches in biologics manufacturing cost companies millions of dollars. A thoroughly characterized process with the right control strategy avoids deviations and failed batches in commercial manufacturing.</p></div></section></div></div><a class="anchor" id="c16517"></a><a class="anchor" id="c16672"></a><div id="t16517" ><div class="spacing-t-m"><section class="content"><div class="outer copy-md"><h2 class="order-5">Goals of process characterization studies? </h2><ul><li>identify process parameters that impact product quality and yield;</li><li>justify manufacturing operating ranges and acceptance criteria;</li><li>identify interactions between process parameters and critical quality attributes;</li><li>ensure that the process delivers a product with reproducible yields and purity.</li></ul></div></section></div></div><a class="anchor" id="c16518"></a><a class="anchor" id="c16673"></a><div id="t16518" ><div class="spacing-t-m"><section class="content"><div class="outer copy-md"><h2 class="order-5">Do I need to include data from a commercial scale in my process characterization study? </h2><p>Yes, because you need to qualify your scale-down model. <a href="/en/blog/what-is-a-qualified-bioprocess-scale-down-model">Scale-down model qualification</a> is an integral part of process characterization studies. Commercial-scale data (setpoint conditions) is necessary to perform a scale-down model qualification. More information can be found in our article <a href="/en/blog/what-is-a-qualified-bioprocess-scale-down-model">what is a bioprocess scale down model?</a> </p></div></section></div></div><a class="anchor" id="c16519"></a><a class="anchor" id="c16674"></a><div id="t16519" ><div class="spacing-t-m"><section class="content"><div class="outer copy-md"><h2 class="order-5">When to start a process characterization study? </h2><p>According to our consulting experience, process characterization studies take at least 12 months to complete. Hence, to be ready before the license application (and have a time buffer), it is best to start a minimum of 16 months before the planned licensure. Biotech companies typically start process characterization activities once it becomes very likely that the product will go to market after successfully completing phase two clinical trials. </p></div></section></div></div><a class="anchor" id="c16520"></a><a class="anchor" id="c16675"></a><div id="t16520" ><div class="spacing-t-m"><section class="content"><div class="outer copy-md"><h2 class="order-5">Statistical data analysis for process characterization studies</h2><p>Statistical data analysis plays a critical role in process characterization studies.</p><p>Biotech companies address the following questions using statistical data analysis for successful process characterizations:</p><ul><li>How do I use available data to support risk assessments (e.g., failure mode and effect analysis)?</li><li>How do I statistically demonstrate that my scale-down models are appropriate?</li><li>Which response variables should be studied in an experimental design?</li><li>How many experiments do I need to conduct to prove a potential critical parameter is not critical?</li><li>How do I state statistically that a parameter is key, non-key, critical, or non-critical?</li><li>How do I statistically define normal operating and proven acceptable ranges?</li><li>How do I stack together multiple DoEs to identify optimization potential and predict out-of-specification (OOS) events?</li></ul></div></section></div></div><a class="anchor" id="c16521"></a><a class="anchor" id="c16676"></a><div id="t16521" ><section class="content-image rect spacing-t-m"><figure class=""><div class="image-container"><img src="/fileadmin/_processed_/4/2/csm_data-visualization_Artboard-22_33c8c2ba1a.png" width="842" height="842" alt="" loading="lazy" /></div></figure></section></div><a class="anchor" id="c16522"></a><a class="anchor" id="c16677"></a><div id="t16522" ><div class="spacing-t-m"><section class="content"><div class="outer copy-md"><h2 class="order-5">Data management in process characterization studies? </h2><p>… process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering a quality product. FDA process validation guideline Authorities stress the importance of data collection in the process validation guidelines. Essential activity in process characterization is the collection of (non-GMP) data to support the regulatory filing. This includes data from</p><ul><li>upstream (fermentation)</li><li>primary recovery</li><li>downstream</li><li>quality</li><li>small scale (laboratory)</li><li>manufacturing scale</li><li>commercial-like runs</li><li>DoE experiments, one factor at a time experiments</li><li>… and many more</li></ul></div></section></div></div><a class="anchor" id="c16523"></a><a class="anchor" id="c16678"></a><div id="t16523" ><section class="content-image ratio-16-9 spacing-t-m"><figure class=""><div class="image-container"><img src="/fileadmin/_processed_/6/5/csm_data-visualization_Artboard-21-copy-2_8743f582f7.png" width="1140" height="640" alt="" loading="lazy" /></div></figure></section></div><a class="anchor" id="c16524"></a><a class="anchor" id="c16679"></a><div id="t16524" ><div class="spacing-t-m"><section class="content"><div class="outer copy-md"><p>In process characterization studies, data structures and types are highly complex (time-series data, one-point quality data, SDS page scans…). Data originates from a broad selection of sources (laboratory equipment, LIMS systems, large-scale manufacturing process control systems, manufacturing execution systems). Data from laboratory (small scale experiments) and large scale manufacturing needs to be integrated for joint analysis.</p><p>Realizing data management is a key question that professionals involved with process characterization studies have to answer.</p><p>Read more about data management and how this supports analytics workflows in <a href="https://savvy-blog.io/best-practices-for-the-analysis-of-bioprocess-fermentation-data/" target="_blank" rel="noreferrer">“best practices for fermentation data analytics”</a>. </p></div></section></div></div><a class="anchor" id="c16525"></a><a class="anchor" id="c16680"></a><div id="t16525" ><div class="spacing-t-m"><section class="content"><div class="outer copy-md"><h2 class="order-5">How does Körber support leading biopharmaceutical companies in process characterization studies?</h2><p><a href="/en/services/pas-x-cmc-innovation-consulting">Körber consulting and statistical services</a> streamlines bioprocess characterization studies and interactions with regulatory authorities such as FDA and EMA by adopting statistical best practices.</p><p><a href="/en/solutions/software/werum-pas-x-savvy">PAS-X Savvy data management, data visualization and data analytics software</a> manages the constant stream of process and quality data in one intuitive software environment.</p></div></section></div></div><a class="anchor" id="c1414"></a><a class="anchor" id="c3162"></a><div id="t1414" ><section class="share spacing-t-m"><p class="copy-md"> Social share </p><ul class="social"><li><a href="https://www.facebook.com/sharer/sharer.php?u=https://www.koerber-pharma.com/en/blog/what-is-process-characterization" class="facebook" target="_blank"></a></li><li><a href="https://twitter.com/home?status=https://www.koerber-pharma.com/en/blog/what-is-process-characterization" class="twitter" target="_blank"></a></li><li><a href="https://www.xing.com/spi/shares/new?url=https://www.koerber-pharma.com/en/blog/what-is-process-characterization" class="xing" target="_blank"></a></li><li><a href="https://www.linkedin.com/shareArticle?mini=true&url=https://www.koerber-pharma.com/en/blog/what-is-process-characterization&title=What%20is%20process%20characterization%3F" class="linkedin" target="_blank"></a></li><li><a href="mailto:?&subject=Interesting%20article&body=Hello%2C%0AI%20found%20the%20following%20interesting%20article%3A%0Ahttps://www.koerber-pharma.com/en/blog/what-is-process-characterization%0A%0AHave%20fun%20reading." class="mail" target="_blank"></a></li></ul></section></div></div><aside class="col-12 col-lg-4"><div class="sidebar"><a class="anchor" id="c1417"></a><a class="anchor" id="c3161"></a><div class="spacing-t-m"><aside class="tx-blog-widget"></aside><aside class="tx-blog-widget"></aside><aside class="tx-blog-widget"></aside><aside class="tx-blog-widget"></aside><aside class="tx-blog-widget"></aside></div></div></aside></div></div><a class="anchor" id="c1415"></a><a class="anchor" id="c3163"></a><div class="spacing-t-m"><div class="blog-detail__comments"><h3 class="comment-title" id="comments"> Comments </h3><p> No comments </p></div></div><a class="anchor" id="c1416"></a><a class="anchor" id="c3164"></a><div class="spacing-t-m"> <div class="form blog-detail__form"> <h3 class="comment-title"> Write comment </h3> <form name="comment" action="/en/blog/what-is-process-characterization?tx_blog_commentform%5Baction%5D=addComment&tx_blog_commentform%5Bcontroller%5D=Comment&cHash=1b2d558c79ccdb2355f694a4abafb63b" method="post"> <div> <input type="hidden" name="tx_blog_commentform[__referrer][@extension]" value="Blog" /> <input type="hidden" name="tx_blog_commentform[__referrer][@controller]" value="Comment" /> <input type="hidden" name="tx_blog_commentform[__referrer][@action]" value="form" /> <input type="hidden" name="tx_blog_commentform[__referrer][arguments]" value="YTowOnt94208b4d0aa3cd72461a502939b33d8c693b436ed" /> <input type="hidden" name="tx_blog_commentform[__referrer][@request]" value="{"@extension":"Blog","@controller":"Comment","@action":"form"}62b401b06980ea231e38e0b6051be91b0b4559be" /> <input type="hidden" name="tx_blog_commentform[__trustedProperties]" value="{"comment":{"hp":1,"name":1,"email":1,"url":1,"comment":1},"submit":1}f1a9a0f35d05e8b637ce3800ee02359279e1a305" /> </div> <div class="form-group js-hp"> <label for="hp"> Please let this field empty </label> <input autocomplete="off" class="form-control" id="hp" type="text" name="tx_blog_commentform[comment][hp]" /> <script type="text/javascript"> var hp = document.getElementsByClassName('js-hp'); 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