The purpose of this paper is to assess and provide recommendations for reducing volumes required for testing of bioburden and sterility of gene therapy products including considerations for clinical stage and process stage (i.e. in-process vs bulk drug substance (BDS)). This paper makes recommendations for reducing the volumes required for testing and therefore conserving product for patients, while remaining compliant and delivering assay and process information on the microbiological status of gene therapy products.
Cell & Gene Therapy
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