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Implementing Process Analytical Technology into Cell and Gene Therapy Manufacturing
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The primary goal of PAT is to measure critical cross parameters (CPPs) that directly affect the essential quality attributes of active pharmaceutical ingredients.</p> <p>However, researchers claim that the <a href="https://www.bioprocessintl.com/upstream-downstream-processing/cell-and-gene-therapy-sector-needs-purpose-built-pat" rel="noopener" target="_blank">pharmaceutical industry needs more purpose-built monitoring technology</a>. Furthermore, the complexities linked to the manufacturing of advanced CGT products have resulted in the slow adoption of PAT in bioprocessing operations. The unique critical quality attributes and heterogeneity of CGTs present challenges for applying PAT approaches to them.</p> <p><strong>Case study</strong></p> <p>A study published in <a href="https://www.nature.com/articles/s41598-023-27998-2#Sec35" rel="noopener" target="_blank"><em>Nature Scientific Reports</em></a><em> </em>explored the applicability of a novel refractometry-based PAT system (Ranger system) in monitoring the metabolic activity of HEK293T cell cultures during lentiviral vector (LVV) production processes in real time.</p> <p>A refractometry-based PAT system relies on a <a href="https://www.europeanpharmaceuticalreview.com/news/183195/novel-pat-system-could-enable-adaptive-process-control/" rel="noopener" target="_blank">novel advanced refractive index (RI) profiling technology</a>. This technology can identify changes in cell culture composition associated with cellular metabolism.</p> <p>Additionally, these systems compare cellular activity under variations of bioreactor operating conditions, giving researchers a more in-depth understanding of real-time culture requirements for specific cell lines and products. </p> <p><strong>Related: </strong></p> <ul> <li><a href="https://oxfordglobal.com/cell/resources/improving-control-strategies-for-bioprocessing-cell-culture" rel="noopener" target="_blank">Improving Control Strategies for Bioprocessing & Cell Culture</a></li> <li><a href="https://oxfordglobal.com/cell/resources/future-directions-for-accelerated-upstream-bioprocessing" rel="noopener" target="_blank">Future Directions for Accelerated Upstream Bioprocessing</a></li> <li><a href="https://oxfordglobal.com/cell/resources/process-development-and-manufacturing-avenues-for-gene-therapy-vectors" rel="noopener" target="_blank">Process Development and Manufacturing Avenues for Gene Therapy Vectors</a></li> </ul> <p>The Ranger system established that there was a correlation between bioreactor pH and culture metabolic activity. Scientists used this information to create a pH operating strategy that resulted in a 1.8-fold increase in metabolic activity compared to an unoptimized bioprocess in bioreactor experiments. </p> <p>Yet, the results also indicated that higher metabolic activity was not related to increased LVV production. Instead, the higher metabolic activity was the cells' response to stress <a href="https://www.bioprocessintl.com/upstream-downstream-processing/cell-and-gene-therapy-sector-needs-purpose-built-pat" rel="noopener" target="_blank">the higher metabolic activity was the cells' response to stress.</a> When pH levels are low the cells increase their metabolic activity to maintain optimal cellular conditions. This demonstrates that there is not always a straightforward relationship between critical process parameters (CPPs) and critical quality attributes (CQAs) in such complex systems.</p> <p><strong>Conclusion</strong></p> <p>Overall, existing solutions for CGT need to be adapted since the same manufacturing processes used for traditional biologics including sensors for basic process parameters are used for CGTs. CGT manufacturing requirements differ from those in biologics, <a href="https://www.cellandgene.com/doc/cell-and-gene-therapy-manufacturing-as-large-scale-biology-0001" rel="noopener" target="_blank">particularly regarding cell culture conditions</a>. </p> <p>However, this case study represents a crucial change from a traditional and static manufacturing model to one that is adaptable and based on a comprehensive scientific understanding of bioprocesses. To summarise, this research shows that integrating PAT into biomanufacturing processes would greatly benefit the CGT field by achieving a better understanding of process parameters and product quality attributes.</p> <p> </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"> 25/03/25 </div> <a href="/nextgen-biomed/online#Innovative%20Contamination%20Control%20in%20Cell%20Therapy:%20Enabling%20Integrity%20and%20Efficiency">Innovative Contamination Control in Cell Therapy: Enabling Integrity and Efficiency</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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