Rapid Mycoplasma Testing Method for Lot-Release of Biotherapeutics
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.