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Regulations

International Regulatory Guidelines

Tests for confirming the absence of mycoplasma contamination in biological products being manufactured in cell cultures are mandatory for the biopharmaceutical and biotechnological industries. Outsourcing these tests to Mycoplasma Biosafety guarantees that the task is carried out by experts that are knowledgeable about all details of the international regulatory standards.

The current industry standard for mycoplasma detection in biological products produced in cell substrates is described and specified in the following international regulatory protocols of the European, US and Japanese regulatory authorities:

  • European Pharmacopoeia (EP), 9th Edition, Chapter 2.6.7., Mycoplasmas (2017).
  • FDA/CBER, (PTC) Points to consider in the characterization of cell lines used to produce biologicals, Attachment 2, Recommended procedures for detection of mycoplasma contamination in biological products produced in cell substrates (1993).
  • FDA/CBER, Guidance for industry: Characterization and qualification of cell substrates and other biological materials used in the production of viral vaccines for infectious disease indications (2010).
  • United States Pharmacopoeia (USP) 40, Chapter <63>, Mycoplasma Tests (2017).
  • FDA, CFR-Code of Federal Regulations Title 21, Part 610 – General Biological Products Standards, Subpart D - Mycoplasma, Section 610.30, Test for Mycoplasma (1998).
  • Japanese Pharmacopoeia (JP), 17th Edition, Mycoplasma Testing for Cell Substrates used for the Production of Biotechnological/Biological Products (2016)
  • VICH, Testing for the Detection of Mycoplasma Contamination, GL34 (Biologicals: Mycoplasma), (2014).

With the exception of the 21CFR610.30 testing protocol, the regulatory guidelines include two methods for regulatory mycoplasma testing, which both have to be applied in order to detect all relevant mycoplasmas:

  • The broth and agar cultivation procedure
  • The indicator cell culture method, applying a DNA-specific fluorochrome staining procedure

Besides these conventional culture methods, the EP and JP guidelines also consider mycoplasma testing by NAT-based mycoplasma detection methods and describe the validation requirements for these methods.

 

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