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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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The Dedham Group's Jennifer Klarer, M.Sc.Eng., partner and head of cell & gene therapy, joins Erin Harris on this episode of Cell & Gene: The Podcast for a deep dive into pricing and value for CGTs. Listen in as Klarer shares a detailed breakdown of the most misunderstood aspects of cell and gene therapy pricing, value, and affordability. |
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Expert panelists J. Andrew Case (Andy) and Daniel Getts cover the biggest bottlenecks facing mRNA cancer vaccine manufacturing today. |
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| How Do CGT Requirements Differ Between FDA And EMA? | Article | By Michael Cooper, Pharmatech Associates - A USP Company | Examine the similarities and differences between the FDA's and the European Medicines Agency's approach to cell and gene therapies to understand where perspectives align and where they diverge. |
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| How To Adapt Efficiently To A New Era Of Supply Chain Manufacturing | Article | By Stephen Aiken and Allison Jackson, Ajinomoto Bio-Pharma Services | It’s no secret – COVID-19 changed things. Now, as the pharma supply chain settles into a new normal, executives are shifting focus to better identify reliable, resilient, and forward-thinking partners. |
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| Development Of A Downstream Processing Platform For AAV | Poster | By Jule Greschok, Mathias Kahl, and Dr. Thomas Kreisig, IDT Biologika | There is a growing need for innovative solutions that reduce costs while maintaining high product quality. This poster presents investigations to derive an economic and scalable method for purification of AAV. |
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