Regulators require that the cell culture-based bioprocesses used for manufacturing protein therapeutics, vaccines, and cell and gene therapy products be tested to ensure they are mycoplasma-free. Traditionally, testing was done using a culture-based, 28-day mycoplasma test. More recently, PCR-based alternatives have evolved, driven by an industry move to shorten lot disposition cycles and the emergence of cell-based therapeutics that require a more rapid test. Recent regulatory guidance allows manufacturers to select rapid tests – as long as they are validated to demonstrate sensitivity and specificity that are comparable to or that improve upon traditional tests. The big question: how should manufacturers respond?
In this eBook, discover how the MycoSEQ™ Mycoplasma Detection System is being used in the real world to accelerate testing. This eBook includes information, case studies, user tips, and more.
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