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By Andrew Walsh, Thomas Altmann, Joshua Anthes, Ralph Basile, James Bergum, Ph.D., Alfredo Canhoto, Ph.D., Stéphane Cousin, Hyrum Davis, Parth Desai, Boopathy Dhanapal, Ph.D., Jayen Diyora, Igor Gorsky, Benjamin Grosjean, Richard Hall, Ovais Mohammad, Mariann Neverovitch, Miquel Romero-Obon, Jeffrey Rufner, Siegfried Schmitt, Ph.D., Osamu Shirokizawa, Steven Shull, Stephen Spiegelberg, Ph.D., and John VanBershot | This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices. | |
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| Vial Adapter Considerations For Cell And Gene Therapy Applications | Article | By Krishnendu Khan, Ph.D., Henry Nguyen, Bridget Moran, Manali Potnis, Ph.D., Vivek Bhatnagar, West Pharmaceutical Services, Inc. | Review features that need to be considered to choose a vial adapter for cell and gene therapy drug products and a case study where vial adapter transfer devices have been used to extract lentiviruses. |
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| CHOp Your Protein Production Timelines | Webinar | MaxCyte, Inc. | How can you leverage flow electroporation technology to drive your biologics development forward and deliver gram-scale transient protein production within two weeks? |
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| Revolutionizing Cell Therapy Manufacturing With AI | Webinar | Invetech | Discover how AI can optimize processes, improve efficiency, and enhance the understanding of cellular processes, ultimately leading to more effective and personalized patient treatments. |
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| Using Robotics In The ATMP Space | Article | By Josh Russell, AST | With regulatory requirements and GMP recommendations trending towards less human interaction and more robotic automation, robotics is the way of the future for the ATMP industry. |
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| Viral Vectors: Are We There Yet? | Article | By Caitlyn Smith and Ratish Krishnan, MilliporeSigma | What must we do as an industry to continue the momentum of cell and gene therapies and ensure these revolutionary treatments become a reality for patients who need them? |
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| Tackling Allogeneic Immunotherapy's Scale-Up Bottleneck | Application Note | PBS Biotech, Inc. | New bioreactor technology provides an optimal environment for shear-sensitive cells, addressing key scale-up challenges for allogeneic therapies from research to commercial production. |
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