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By Darius Pillsbury and Tiffany Baker, ValSource, Inc. | Establishing a robust contamination control strategy for advanced therapy medicinal products, also referred to as cellular and gene therapy products, is of utmost importance. In this article, the authors introduce the aseptic risk evaluation model (AREM), which is compliant with the evolving global regulatory landscape and best practices. |
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Experts at a Cell & Gene Live event discussed the use of mRNA technology in cancer immunotherapy, including a brief overview of the different approaches being used to leverage mRNA technology. |
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| Flexible Facility Design For Multi-Product Manufacturing Of CGTs | Article | By Emily Moran, The Center for Breakthrough Medicines | Discover principles for the success of advanced therapy manufacturing facilities that benefit developers with established platform processes to sponsors and CDMOs involved in large-scale manufacturing. |
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| ICH And USP <1220>: Implementing A QbD Analytical Framework | White Paper | By Brian Glass, Pharmatech Associates - A USP Company | The ICH and the USP are currently finalizing draft guidelines that describe a new paradigm for analytical development based on the Quality by Design approach used for development. |
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