Bioburden and sterility testing: how to conserve gene therapy product

Gene therapy manufacturing processes produce low yields, particularly in early product development stages. Yet the products are subject to the same regulatory release criteria and expectations as those used for traditional microbiology testing on biologics/pharma products producing significantly higher yields. Often, if gene therapy manufacturers were to adhere to current release requirements, the outcome would be little, if any, remaining product for the clinic or patients who often have no other treatment options.

The challenge is to reduce the volumes required for testing to conserve product for patients while remaining compliant and delivering assay and process information to ensure the microbiological safety of gene therapy products.