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    Microbiological Safety and Adventitious Agents Standards for TEMPS

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    Microbiological contamination and adventitious virus contamination can be introduced into TEMPs from source materials, such as cells, cell culture media, scaffolds, and growth factors. Contamination can occur during isolation and expansion of cells, production of scaffolds and growth factors, and product manufacturing. Contamination may also arise during storage due to the inability to use sufficiently stringent preservation and storage methods without destroying the TEMPs' function.

    Standard safety testing for pathogens may not be suitable for TEMPs. New rapid microbiological detection methods and PCR assays for mycoplasma and virus may enable preliminary product release. Cleaning and sanitization of equipment can be validated using a combination of traditional and new, more rapid methods. When there are significant processing steps, clearance studies can provide a further assurance of freedom from unwanted adventitious agents.


    adventitious agents, biological safety, TEMPs, virus, microorganisms, testing methods, assays

    Author Information:

    Sofer, G
    Director Regulatory Services, BioReliance, Rockville, MD

    Committee/Subcommittee: F04.43

    DOI: 10.1520/STP11645S