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| Webinar: Navigating Regulatory Challenges For Cell And Gene Products In 2024 And Beyond | A multi-discipline panel of experts will discuss the importance of ancillary and starting materials management control strategies for CGT product development, recent FDA regulatory developments for expedited regulatory pathways for cell and gene therapy products (specifically the recent regulatory initiatives for improving efficiency of accelerated approval pathway), and regulatory considerations crucial for using companion diagnostics in CGT. Click here to learn more. |
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On this episode of Cell & Gene: The Podcast, Kite Pharma's Global Head of Technical Operations Christopher McDonald talks to Host Erin Harris about Kite's recent FDA approval of manufacturing process change resulting in reduced median turnaround time for Yescarta. |
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By Life Science Connect Editorial Staff | Deciding whether to bring manufacturing in-house or outsource it to a partner can be a daunting decision, particularly as market forces continue to put pressure on small biotechs. |
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| Utilizing Multiplex ddPCR To Streamline Viral Gene Therapy Workflows | Article | By Tara Quang and Michael Baker, FUJIFILM Diosynth Biotechnologies | Analytical technologies like Droplet Digital PCR (ddPCR) provide a more rapid and robust approach to nucleic acid quantification for better sensitivity, accuracy, and precision in therapeutic development. |
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| CRISPR RNPs And The Future Of Cell And Gene Therapy | White Paper | By Thomas Lynch, Ph.D., Aldevron | Explore the potential of ribonucleoprotein (RNP) to deliver CRISPR materials more accurately, efficiently, and effectively, as well as the manufacturing challenges which require further attention. |
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| Accelerate Your Flight Plan To Market | Article | Charles River | A number of CGT programs beginning Phase 3 trials experience CMC- and safety-related disruptions. Discover how to avoid development pitfalls and choose the right manufacturing path to clinic. |
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| Successfully Managing CGT Life Cycles | Article | By Mike Paglia, ElevateBio | Learn more about the right processes to utilize across the cell and gene therapy life cycle and why having the right people to develop and execute those processes can ensure success. |
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