T/SHPPA 030-2025 Requirements for validating rapid mycoplasma testing of biologics by nucleic acid amplification techniques

Scope

This document sets forth the verification principles and requirements for the detection of mycoplasma nucleic acid amplification techniques in biopharmaceuticals. This document applies to the verification management of mycoplasma nucleic acid amplification techniques in biopharmaceuticals produced using eukaryotic cell lines (including recombinant vaccines, monoclonal antibodies, conjugated antibodies, viral vectors, etc.) and other biological culture systems (including inactivated vaccines produced in chicken embryos, etc.), as well as cell therapy products. The verification of mycoplasma nucleic acid amplification techniques used in the R&D, clinical trials, and intermediate process control of biopharmaceuticals and cell therapy products can be implemented as a reference. Mycoplasma is an increasingly overlooked contaminant source in the production of biopharmaceuticals. According to current regulations and detection methods, it typically refers to microorganisms of the Mollicutes order. They are the smallest and simplest single-celled microorganisms currently known, with polymorphic characteristics. The sterilizing filters used in the production process cannot effectively intercept them; they are resistant to common antibiotics; and they are adhesive, easily contaminating production cell lines and being difficult to remove. Eukaryotic cell lines are susceptible to mycoplasma contamination, which can lead to a decline in the efficiency of the reaction system and product quality, resulting in cost and production time losses. For products directly used in patient treatment, such as cell therapy products, the control of mycoplasma contamination is particularly important. Existing mycoplasma detection methods take a long time, so rapid mycoplasma detection methods can be established through verification for use in intermediate process control or product release inspection. This document is used to guide the verification of mycoplasma nucleic acid amplificati

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