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| Webinar: AAV Analytics: Key Considerations When Developing a Clinical Program | Challenges like inadequate analytical development can stall an advanced therapy's development. At Andelyn, method validation has been integral to our processes. We develop assays from our research to meet the standards of large-scale GMP production of plasmids and viral vectors. Please join Andelyn to learn key considerations for taking your AAV gene therapy from concept to commercialization with advanced analytics. Click here to learn more. |
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By Takehiro Okumura and Zeb Khan, Takeda Pharmaceuticals | Would you ever need to follow GMP standards in workspaces where GMP is not required or possible? This article digs into why, when, and how to follow the principles of GMP. |
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Explore why expectations grow along the curve and why understanding what's expected early on is important. |
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| Assessing Therapeutic Potency: The Role Of Early Characterization Studies | Article | By Rubina Pal and Eva Morschl, Comprehensive Cell Solutions, A Business Unit of NYBC Enterprises | Early product characterization can serve to uncover crucial information about an advanced therapeutic candidate, affording new insight into its CQAs and helping to shape better analytical assays. |
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| Transform Your Cell Therapy CDMO From Service Provider To Partner | Article | By Dr. David Smith and Dr. Chathuranga De Silva, BioCentriq | Review what a cell therapy CDMO will do to demonstrate that not only are they strong and capable but also a true partner in what will be the most important years of your company's journey to success. |
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