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Rapid Mycoplasma Testing Method for Lot-Release of Biotherapeutics

Rapid Mycoplasma Testing Method for Lot-Release of Biotherapeutics content piece image

Mycoplasma contamination of manufacturing cell cultures is rare, but presents a threat for biologics manufacturers. 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.

Download this eBook to learn how to:

  • Save reagents and prevent error
  • Optimize the method for a given process
  • Collect data at different cell densities and viabilities

Created and originally published by The Medicine Maker.