Whitepaper: Global regulators’ FAQs on CMC in IND/BLA filing

Mammalian cell cultures used in the manufacturing of therapeutics must be tested to ensure lack of mycoplasmal contamination. Previously, the only test for mycoplasma accepted by regulatory agencies was a culture-based test such as the test detailed in USP <63>. Currently, regulatory agencies globally accept nucleic acid testing methods as an alternative to the 28-day test, following acceptable validation, submission and review. This whitepaper will help readers understand some of the regulatory inquiries related to rapid mycoplasma testing and validation, and provide insight into potential responses.

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