Bionique Testing Laboratories, Inc. services

At Bionique Testing Laboratories, our objective is to meet your need for rapid and reliable mycoplasma testing. Whether you are looking for a contract laboratory to process your routine testing submissions or work closely with you to qualify and/or validate an alternative method, we can help.

This test is designed for the Mycoplasma screening of Serum products. The service consists of the inoculation on an indicator cell line followed by the performance of DNA fluorochrome staining assay. The enrichment component of this method enhances detection of non-cultivable Mycoplasma species.

The purpose of Bionique’s M-800 Mycoplasma Test is to detect the presence of agar cultivable and non-cultivable mycoplasma species in viral vaccines produced in cell substrates and similar products. The test is also recommended for virus seed stocks, master / working cell banks, cells substrates, and other biological products produced in cell. Total Testing Time: 28 days. Sample Requirements: Minimum Test Volume = 12 mL Test Article and 12 mL of Control Fluid. GMP Service.