Overcoming the Challenges in Cell Therapy Manufacturing

<!doctype html><html lang="en"><head> <meta charset="utf-8"> <title>Overcoming the Challenges in Cell Therapy Manufacturing</title> <link rel="shortcut icon" href="https://oxfordglobal.com/hubfs/OXFORD_GLOBAL-LOGO_SYMBOL.jpg"> <meta name="description" content="Udayanath Aich at Bristol Myers Squibb, leads a Discussion Group on leveraging advanced technologies and analytical development strategies."> <meta name="viewport" content="width=device-width, initial-scale=1"> <meta property="og:description" content="Udayanath Aich at Bristol Myers Squibb, leads a Discussion Group on leveraging advanced technologies and analytical development strategies."> <meta property="og:title" content="Overcoming the Challenges in Cell Therapy Manufacturing"> <meta name="twitter:description" content="Udayanath Aich at Bristol Myers Squibb, leads a Discussion Group on leveraging advanced technologies and analytical development strategies."> <meta name="twitter:title" content="Overcoming the Challenges in Cell Therapy Manufacturing"> <style> a.cta_button{-moz-box-sizing:content-box !important;-webkit-box-sizing:content-box !important;box-sizing:content-box !important;vertical-align:middle}.hs-breadcrumb-menu{list-style-type:none;margin:0px 0px 0px 0px;padding:0px 0px 0px 0px}.hs-breadcrumb-menu-item{float:left;padding:10px 0px 10px 10px}.hs-breadcrumb-menu-divider:before{content:'›';padding-left:10px}.hs-featured-image-link{border:0}.hs-featured-image{float:right;margin:0 0 20px 20px;max-width:50%}@media (max-width: 568px){.hs-featured-image{float:none;margin:0;width:100%;max-width:100%}}.hs-screen-reader-text{clip:rect(1px, 1px, 1px, 1px);height:1px;overflow:hidden;position:absolute !important;width:1px} </style> <link rel="stylesheet" href="https://oxfordglobal.com/hs-fs/hub/8696823/hub_generated/template_assets/135726131582/1732113079147/git/og-stage/css/main.min.css"> <link rel="stylesheet" href="https://cdn.oxfordglobal.com/fontawesome/6.5.1/css/fontawesome.min.css"> <link rel="stylesheet" href="https://cdn.oxfordglobal.com/fontawesome/6.5.1/css/brands.min.css"> <link rel="stylesheet" href="https://cdn.oxfordglobal.com/fontawesome/6.5.1/css/solid.min.css">  <style id="hs_editor_style" type="text/css"> #hs_cos_wrapper_module_17019620504109 { display: block !important; margin-bottom: 0px !important } </style>  <script> var _hsp = window._hsp = window._hsp || []; window.dataLayer = window.dataLayer || []; function gtag(){dataLayer.push(arguments);} var useGoogleConsentModeV2 = true; var waitForUpdateMillis = 1000; if (!window._hsGoogleConsentRunOnce) { window._hsGoogleConsentRunOnce = true; gtag('consent', 'default', { 'ad_storage': 'denied', 'analytics_storage': 'denied', 'ad_user_data': 'denied', 'ad_personalization': 'denied', 'wait_for_update': waitForUpdateMillis }); if (useGoogleConsentModeV2) { _hsp.push(['useGoogleConsentModeV2']) } else { _hsp.push(['addPrivacyConsentListener', function(consent){ var hasAnalyticsConsent = consent && (consent.allowed || (consent.categories && consent.categories.analytics)); var hasAdsConsent = consent && (consent.allowed || (consent.categories && consent.categories.advertisement)); gtag('consent', 'update', { 'ad_storage': hasAdsConsent ? 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Bristol Myers Squibb is a global biopharmaceutical company committed to discovering, developing, and delivering innovative medicines to patients with serious diseases. Aich has extensive experience and management skills in analytical chemistry, and CMC analytical strategies for early, late, and commercial biologics. In addition, he is leading analytical control strategy for late-stage biologics and small molecules.</p> <p> </p> <div class="wp-block-image"> <figure class="alignright size-full is-resized"><img class="wp-image-34979" src="https://oxfordglobal.com/hs-fs/hubfs/Website/Images/Resources/Cell%20and%20Gene/Kelly-Kemp-Senior-Director-of-CMC-at-Viacyte.jpg?width=155&height=156&name=Kelly-Kemp-Senior-Director-of-CMC-at-Viacyte.jpg" alt="Overcoming the Challenges in Cell Therapy Manufacturing" width="155" height="156" srcset="https://oxfordglobal.com/hs-fs/hubfs/Website/Images/Resources/Cell%20and%20Gene/Kelly-Kemp-Senior-Director-of-CMC-at-Viacyte.jpg?width=78&height=78&name=Kelly-Kemp-Senior-Director-of-CMC-at-Viacyte.jpg 78w, https://oxfordglobal.com/hs-fs/hubfs/Website/Images/Resources/Cell%20and%20Gene/Kelly-Kemp-Senior-Director-of-CMC-at-Viacyte.jpg?width=155&height=156&name=Kelly-Kemp-Senior-Director-of-CMC-at-Viacyte.jpg 155w, https://oxfordglobal.com/hs-fs/hubfs/Website/Images/Resources/Cell%20and%20Gene/Kelly-Kemp-Senior-Director-of-CMC-at-Viacyte.jpg?width=233&height=234&name=Kelly-Kemp-Senior-Director-of-CMC-at-Viacyte.jpg 233w, https://oxfordglobal.com/hs-fs/hubfs/Website/Images/Resources/Cell%20and%20Gene/Kelly-Kemp-Senior-Director-of-CMC-at-Viacyte.jpg?width=310&height=312&name=Kelly-Kemp-Senior-Director-of-CMC-at-Viacyte.jpg 310w, https://oxfordglobal.com/hs-fs/hubfs/Website/Images/Resources/Cell%20and%20Gene/Kelly-Kemp-Senior-Director-of-CMC-at-Viacyte.jpg?width=388&height=390&name=Kelly-Kemp-Senior-Director-of-CMC-at-Viacyte.jpg 388w, https://oxfordglobal.com/hs-fs/hubfs/Website/Images/Resources/Cell%20and%20Gene/Kelly-Kemp-Senior-Director-of-CMC-at-Viacyte.jpg?width=465&height=468&name=Kelly-Kemp-Senior-Director-of-CMC-at-Viacyte.jpg 465w" sizes="(max-width: 155px) 100vw, 155px"></figure> </div> <p> </p> <p>Joining Aich was <strong>Kelly Kemp, Senior Director of CMC at ViaCyte, a Vertex Company</strong>. ViaCyte is a regenerative medicine company focused on the discovery, development, and commercialisation of novel cell replacement therapies. As a leader in process development, Kemp has had the opportunity to optimise GMP processes for multiple cell-based therapies. Kemp has extensive experience in dissecting and characterising processes and subsequently working with cross-functional teams to implement improvements, which in turn benefit patients.</p> <p> </p> <h2>Drug Complexity is Ever Increasing</h2> <p> </p> <p>Kemp opened the discussion by talking about the current state of the cell therapeutic landscape. “As we've gone through development, starting with small molecules, to biologics such as proteins, and finally towards cells, the complexity has increased immensely.” She continued: “this is something that we need to tackle in our field, and hopefully collaborate to find the solutions as quickly as possible so we can get these therapies to market.”</p> <p> </p> <p>Aich agreed and confirmed that the constantly evolving drug complexity is a priority of both the cell and gene therapy field and the biologics field. “There is a lot of connection between biologics and the small molecule space from the cell therapy side, which have tremendous value.”</p>  <h2>Production Challenges for New Cell Therapies</h2>   <p>A key topic of discussion included the difficulties of process and analytical development. As Kemp pointed out, “the process is the product, often with cell therapy.” Beginning process development as early as possible is necessary for ensuring an optimal developmental timeline and functional workflow. Strategies to achieve this could be to try and lock down the process during phase III production to coincide with the commercial production process to avoid having to perform clinical bridging studies to prove comparability.</p>   <p>However, this is easier said than done. One audience member spoke of the practically and relevantly short window of opportunity for this. “The reality is that a lot of these projects go by so quickly,” they explained. In cases where there are high unmet needs in a particular disease area, there may not even be a phase III available for development. “Ensuring early lockdown is an ideal scenario, but in a reality where everything is so accelerated, it often is not possible.”</p>   <ul><li><a href="https://oxfordglobal.com/cell/resources/looking-into-the-crystal-ball-the-future-of-disruptive-cell-and-gene-therapy-manufacturing/" target="_blank" rel="noreferrer noopener">Looking into the Crystal Ball: The Future of Disruptive Cell and Gene Therapy Manufacturing</a></li><li><a href="https://oxfordglobal.com/cell/resources/aav-manufacturing-using-osmolality/" target="_blank" rel="noreferrer noopener">AAV Manufacturing Using Osmolality</a></li><li><a href="https://oxfordglobal.com/cell/resources/developing-meaningful-assays-balancing-biological-significance-and-qc-compatibility/" target="_blank" rel="noreferrer noopener">Developing Meaningful Assays: Balancing Biological Significance and QC-Compatibility</a></li></ul>   <p></p>   <p>Kemp responded by acknowledging that some processes will inevitably be less clearly defined due to external considerations but that the benefits of early development and characterisation are undeniable. Other challenges and solutions discussed covered developing scale-up technologies to meet forecast requirements, lowering analytical costs by developing relevant<em> ex vivo </em>methods, and reducing reliance on single external vendors via raw material improvements.</p>   <h2>Analytical Development Strategies for Cellular Therapies</h2>   <p>Conversation then turned to demonstrating process comparability with characterisation and control strategies. Aich explained that “the need to reliably demonstrate product comparability with process changes is no easy task.” Developing multiple test methods to identify predictive quality control attributes (CQAs) is one solution.</p>   <p>When asked by the audience how to go about selecting the most applicable methods for control strategies, Aich indicated the utility of adopting practises from the biologics domain. “Start from the very beginning,” he instructed. “Following the typical pathway of control strategies means you must take the raw materials and the instrumental parameters and put them through a process testing software.”</p>   <blockquote class="wp-block-quote is-style-large"><p>"The need to reliably demonstrate product comparability with process changes is no easy task.”</p></blockquote>   <p>Once the end drug product testing is complete, relevant stability, extended characterisation, and comparability will become measurable. “But the most important thing to remember is that end product testing is constantly evolving along with other critical steps such as process testing and real-time release testing,” Aich advised.  </p>   <h2 id="h-what-s-next-in-the-discussion-group-series">What's Next in the Discussion Group Series?</h2>   <p>The session concluded with some final thoughts on leveraging advanced technologies to further improve cell therapy analytics and development. To watch an on-demand recording of this Discussion Group, and to discover more about the exclusive offerings from our Cell Membership Community, <a href="https://oxfordglobal.com/cell/membership/" target="_blank" rel="noreferrer noopener">click here</a>.</p>   <p>We will continue our Discussion Group series in November with a session focusing on<strong> Advanced and Predictive 3D Cell Culture Models</strong>, led by Alishba Khalid, CEO of Crystal-Bio Ltd. To gain exclusive access to the upcoming sessions in our Cell series, <a href="https://oxfordglobal.com/cell/upcoming/" target="_blank" rel="noreferrer noopener">click here</a>.<br></p>   <p><em>Want to find out more about the latest stem cell therapy news? Register now for <a href="https://oxfordglobal.com/" target="_blank" rel="noreferrer noopener">Oxford Global</a>â€˜s <a href="https://oxfordglobal.com/3d-cell-culture/" target="_blank" rel="noreferrer noopener">3D Cell Culture</a> congress incorporates key trends and innovative technologies to accelerate the adoption of 3D models in preclinical research via advanced development, validation and application strategies.</em><br></p>  <div class="content-body-footer"> </div> </div> <div class="content-sidebar"> <div class="related-articles"> <h3 class="center">Related Resources</h3> <div class="article"> <a href="/nextgen-biomed/resources/sgs-biologics-services"> <div class="cover-graphic"> <img src="https://oxfordglobal.com/hubfs/Website/Images/Resources/Cell%20and%20Gene/Cell%20%26%20Gene%20Whitepaper.png" class="cover-graphic-image"> </div> </a><div class="content"><a href="/nextgen-biomed/resources/sgs-biologics-services"> <h4> SGS Biologics Services </h4> <div class="abstract"> </div> <div class="read-more"> <a href="/nextgen-biomed/resources/sgs-biologics-services" class="read-more-link">Read More</a> </div></a> </div> </div> <div class="article"> <a href="/nextgen-biomed/resources/sgs-biosafety-characterisation-services"> <div class="cover-graphic"> <img src="https://oxfordglobal.com/hubfs/Website/Images/Resources/Cell%20and%20Gene/Cell%20%26%20Gene%20Whitepaper.png" class="cover-graphic-image"> </div> </a><div class="content"><a href="/nextgen-biomed/resources/sgs-biosafety-characterisation-services"> <h4> SGS Biosafety & Characterisation Services </h4> <div class="abstract"> </div> <div class="read-more"> <a href="/nextgen-biomed/resources/sgs-biosafety-characterisation-services" class="read-more-link">Read More</a> </div></a> </div> </div> </div> <div class="related-online-activities"> <h3 class="center">Related Online Activities</h3> Join the conversation with our upcoming Monthly Science Exchanges and Webinars: <div class="online-activity"> <div class="heading-smallcaps"> 01/11/24 </div> <a href="/nextgen-biomed/online#Process%20Challenges%20in%20ATMP%20Development:%20Overcoming%20Hurdles%20for%20Successful%20Manufacturing">Process Challenges in ATMP Development: Overcoming Hurdles for Successful Manufacturing</a> </div> </div> </div> </div> </div> </div> </div> <div class="newsletter-cta"> <h2 class="heading">Subscribe to our newsletter</h2> <div class="message"> Sign up for our monthly Newsletter to keep up with all things NextGen Biomed </div> <div class="button-wrapper"> <a href="#" class="button hs-cta-trigger-button hs-cta-trigger-button-177053686099">Newsletter Sign-Up</a> </div> </div> </main> <div data-global-resource-path="git/og-stage/templates/partials/footer.html"><footer class="website-footer flex flex-column g-20"> <div class="footer-columns"> <div class="footer-column"> <a href="https://oxfordglobal.com" class="site-logo-link"> <img src="https://oxfordglobal.com/wp-content/uploads/2023/03/Oxford-Global-Logo-Stacked-Websize.png" class="site-logo"> </a> </div> <div class="footer-column"> <h3>Brands</h3> <ul> <li> <a href="/precision-medicine/">Precision Medicine</a> </li> <li> <a href="/discovery-development/">Discovery & Development</a> </li> <li> <a href="/nextgen-biomed/">NextGen Biomed</a> </li> </ul> </div> <div class="footer-column"> <h3>Services</h3> <ul> <li> <a href="https://oxfordglobal.com/in-person-services/"> In-Person Services </a> </li> <li> <a href="https://oxfordglobal.com/digital-marketing-services/"> Digital Marketing Services </a> </li> </ul> <h3>Upcoming Events</h3> <ul> <li> <a href="https://oxfordglobal.com/calendar/"> Event Calendar </a> </li> </ul> </div> <div class="footer-column"> <h3>Company</h3> <ul> <li class="elementor-icon-list-item"> <a href="https://oxfordglobal.com/about-us/"> About </a> </li> <li class="elementor-icon-list-item"> <a href="https://oxfordglobal.com/vacancies/"> Vacancies </a> </li> <li class="elementor-icon-list-item"> <a href="https://oxfordglobal.com/csr-policy/"> CSR Policy </a> </li> <li class="elementor-icon-list-item"> <a href="javascript:postMessage({type:'HS_DISPLAY_CALL_TO_ACTION',id:130207947529});"> Contact </a> </li> </ul> </div> <div class="footer-column"> <p> <a href="tel:+441865248455">+44 1865 248 455</a><br> <a href="mailto:help@oxfordglobal.com">help@oxfordglobal.com</a> </p> <p> <strong>Our UK Address:</strong><br> Godstow Court<br> Minns Business Park<br> Botley<br> Oxford, OX2 0JB </p> <p> <strong>Our US Address:</strong><br> 100 Cambridge Street<br> 14th Floor<br> Boston<br> MA 02114 </p> </div> </div> <div class="footer-bottom grid g-20"> <div class="span8 span12-sm span12-md flex flex-column g-10"> <div class="copyright"> © Oxford Global Marketing Ltd. 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Overcoming the Challenges in Cell Therapy Manufacturing