Regenerative medicine products, such as tissue engineering and cell therapies, are unable to undergo the pharmacopoeial methods for terminal sterilization as they are composed of living cells. As such, these products are manufactured in aseptic conditions in production facilities with appropriately controlled environments to prevent microbial contamination.
Microbiological tests on biopharmaceuticals (including raw materials, in-process samples and final products) are performed with a view to either detection or enumeration, and identification of microbial contaminants. Tests for the presence or absence of viable contaminating microorganisms should be conducted at various stages throughout the manufacturing process as part of an overall microbial control testing program. All preparations and substances that are intended for parenteral administration must undergo sterility testing prior to treatment of patients.
Read this white paper to learn how validated, rapid sterility methods better address the needs of cell and gene therapy clients, with faster turnaround and increased throughput.