Harmonized USP <63>
Mycoplasma Test (M-1400)

Bionique is a leading provider of compendial mycoplasma testing to support the release of biologics, biosimilars, combination products, and raw materials.

Testing

Bionique’s Harmonized USP <63> Mycoplasma test (M-1400) was designed to comply with USP <63>; US FDA’s 1993 Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (PTC); Ph. Eur. chapter 2.6.7, and the Japanese Pharmacopoeia 18th Edition, Mycoplasma Testing for Cell Substrates used for the Production of Biotechnological/Biological Products. The test includes both the direct culture and indicator cell culture procedures and is intended for the mycoplasma testing Master Cell Banks (MCB), End of Production (EOP) cells, unprocessed bulk harvest materials and raw materials.

Total Testing Time:
28 days

Sample Requirements:
Minimum Test Volume = 15 mL

As required by USP and EP, a qualification study must be performed to test for the presence or absence of inhibitory substances for each product. This qualification study (M-1450) is recommended only once for any given product unless changes within the sample matrix or manufacturing process occur.

GMP Testing Service Validated Test Method Suitability Testing
M-1400
M-1450

QUALIFICATION

Inhibition Testing For Harmonized USP <63> (M-1450)

The M-1450 mycoplasmastasis assay is designed to determine the presence or absence of product-specific inhibition of mycoplasma growth within the Bionique’s Harmonized USP <63> Mycoplasma Test (M-1400).

The pharmacopoeias (EP and USP) require testing for inhibitory substances in the test article. This qualification study is recommended only once for any given product unless changes within the test article matrix or manufacturing processes occur.

Total Testing Time:
28 days

Sample Requirements:
Minimum Test Volume = 45 mL


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