Lot Release Testing

M-700 FDA Points to Consider Method

This test satisfies the FDA Points to Consider for the Mycoplasma testing of Cell Cultures and Biologicals derived from cell substrates. The procedure is recommended for each lot of product harvest concentrate and the master cell banks, working cell stocks and cell substrates used for the manufacturing of these products. This method consists of the Direct Culture method combined with the Indicator Cell Culture procedure. (GMP service)

M-800 Mycoplasma Test for Human Vaccines and Biologicals Compliance with 21 CFR 610.30

This test is intended for Mycoplasma testing of Vaccines and Biologicals for human use in compliance with 21 CFR 610.30 Subpart D - Test for Mycoplasmas. Bionique enhances the regulatory required 28 day Direct Culture based test by incorporating the Indicator Cell Culture procedure within this service. The addition of the DNA fluorochrome assay with the indicator cell line enhances detection of non-cultivable Mycoplasma species (GMP service).

M-1000 Mycoplasmastasis Validation Study

Bionique offers Mycoplasmastasis studies to validate our M-700 or M-800 Assay for an individual test article. The qualification study is designed to determine the presence or absence of product-specific inhibition of mycoplasma growth within our assays. This test is recommended only once for any given final product unless changes within the test article matrix or manufacturing processes occur.