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| As the patient’s immune cells are the starting materials, inherent biological variability leads to CAR-T manufacturing. Additional critical raw materials also have batch-to-batch variability, which means the entire production process is a constant balancing act of adjusting the manufacturing process to create standardized manufacturing. Join Cell & Gene Live for a discussion on practical ways to overcome the challenges associated with batch-to-batch variation. Registration is free thanks to the support of Entegris. |
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By Mark Haydock, biologics CMC consultant, Agile Biologics Consulting LLC | There is a growing popularity of adeno-associated virus (AAV) for delivering in-vivo gene therapies, a burgeoning preference for transient transfection systems by biologics companies, and an increasing number of CDMOs offering this system as a platform process. This article describes a transient transfection AAV manufacturing process that uses a triple plasmid transfection strategy into HEK293T cells. |
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Balance out the risks that come with adding new and exciting technology to your operations by ensuring that you have a strong foundation. |
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| Set Your Oversight Early, But Do Not Dictate All The Rules | Q&A | Pharmatech Associates - A USP Company | As more and more sponsors partner with CDMOs to leverage their expertise and capabilities, see why utilizing the right framework to manage a partner is crucial for the relationship to function optimally. |
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| Innovations In ADC Technologies | Webinar | Catalent | Examine the drivers behind the recent successes in the clinic, current challenges with development and manufacturing, and what the future might hold for the ADC industry. |
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| T Cell Cryopreservation: Comparing Rigid Polymer Vials And Flexible Bags | Poster | By Samuel A. Molina, Katie Glen, Jon Harriman, Crystal Kraft, Robert Thomas, and Alexander Lyness, West Pharmaceutical Services, Inc. | This work evaluates the performance of rigid 50 mL COP vials as an alternative for cryogenic storage of T cells compared to existing flexible cryogenic bags. |
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| The shift toward addressing diseases at the genetic level is propelled by tools like CRISPR technology and innovative delivery methods such as RNPs. Improved understanding of cellular mechanisms complements these advancements. The importance lies in the potential for RNPs to make gene editing more precise and efficient, broadening its applicability across various genetic conditions. This progress promises enhanced therapeutic outcomes, increasing feasibility in tackling diverse diseases at the genetic level. Learn more |
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