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Ensuring Biotherapeutic Products Are Mycoplasma-Free

mAbs3 mycoplasma 3rd party lp ebook

Vaccines, cell and gene therapy products must be certified as mycoplasma-free to meet regulatory requirements. Hence, mycoplasma contamination testing is a vital step in the biologics manufacturing process.

Traditional, culture-based tests are often insufficient for the fast-paced nature of cell-based therapeutics production workflows. While rapid PCR tests are now available, not all demonstrate the sensitivity and specificity standards to meet regulatory requirements.

This eBook highlights the latest rapid, cost-effective and robust assays to support sterility in biotherapeutic production.

Download this eBook to discover:

  • A rapid and compliant PCR-based test
  • How to navigate evolving regulatory guidelines
  • Solutions to support the qualification, validation, regulatory submission and review of novel therapeutic products
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