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| Webinar: Quality Roundtable: Raw Material Planning for Tech Transfer and Scaling Biologics | Join fellow biopharmaceutical professionals as they discuss strategies for transitioning biopharmaceuticals from research to clinical and commercial manufacturing. Topics include overcoming tech transfer challenges, vendor certificates of analysis, raw material selection, process performance qualifications, regulatory requirements, and inventory management. The panel will address questions on these key areas to help navigate quality and planning decisions in biologic progression. Click here to learn more. |
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FOCUS ON PROCESS ENGEINEERING |
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By Tyler Menichiello, contributing editor, Bioprocess Online | In this segment of the executive roundtable discussion, our panelists reflect on recent advances in cell therapy manufacturing and discuss active areas of innovation. | |
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| The Path To Digital CPV | Article | ValGenesis | Get to know and embrace a digital CPV approach to proactively detect and address process deviations, ensuring continuous improvement and enhanced quality throughout the product lifecycle. |
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| Optimizing rAAV Productivity: The Role Of Viable Cell Density | Poster | By N. Arranz-Emparan, L. Reina-Romeo, A. Gonzalez-Pereira, et al., Viralgen | A Design of Experiment (DoE) model was developed to address the multifactorial nature of large-scale transfection, where variables like viable cell density (VCD) and DNA amount jointly influence efficiency. |
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| Bringing CRISPR Into The CAR-T Process | Article | By Patrick Paez, Ph.D., Aldevron | CAR-T cell therapy has been limited by high costs and lengthy manufacturing. Novel methods are bringing exciting advancements in CRISPR-based gene editing that hold promise for overcoming hurdles. |
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| 5 Key Elements Of Quality By Design In Pharma | Article | By Ave Love, MasterControl, Inc. | Learn about the advantages of embedding quality throughout design and manufacturing, explore five practical elements of QbD in pharmaceuticals, and discover how a QMS can support QbD. |
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| Getting CMC Right For Emerging Technologies | Article | Cytiva | Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics. |
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PROCESS ENGINEERING SOLUTIONS |
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| RNA Sandbox with Johns Hopkins RNA Innovation Center's Jeff Coller, Ph.D. and Michelle Kim, Ph.D. | Don’t miss this week’s Business of Biotech podcast! We’re joined by Drs. Jeff Coller and Michelle Kim, along with Advancing RNA’s Anna Rose Welch, to discuss the Johns Hopkins University RNA Innovation Center. Learn how this groundbreaking venture supports RNA developers and aspiring business builders with unique resources and opportunities. Tune in to discover the Center’s origins, offerings, and how it’s shaping the future of RNA innovation. |
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| 6 Questions To Ask When Vetting Serum Suppliers | Article | Corning Life Sciences | There are some pointed questions that manufacturers need to ask their suppliers before stocking or restocking serums in their lab. Here are six they can start with. |
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