Mycoplasma Testing Services

Bionique® Testing Laboratories, Inc. is committed to providing our clients with the very best in products and services. Additionally, we offer contractual services to meet client specific needs in our areas of expertise - mycoplasma and cell culture. We provide a wide range of services compliant with cGMP standards (Current Good Manufacturing Practices) Federal Regulations 21 Parts 210 and 211.

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Cell Culture Testing

Bionique® offers a variety of mycoplasma testing services and products for cell cultures used in research or biopharmaceutical manufacturing including Real-Time Polymerase Chain Reaction (PCR) Mycoplasma Tests and United States Pharmacopeia (USP) Mycoplasma Tests.

Raw Materials Testing

A variety of mycoplasma testing services are offered for detecting contamination in sera, media and other bioproducts including Fluorochrome staining and USP Mycoplasma Tests.

Lot Release Testing

Quality control mycoplasma testing for final lot release of vaccines and biologics in accordance with United States FDA regulations.

Mycoplasma Clean up and Elimination

Bionique® offers a clean up service to remove mycoplasma from contaminated cell cultures.

Mycoplasma Reference Standards

Provides support to the evaluation of emerging PCR-based rapid microbial methods (RMM) for the detection of mycoplasma. 

Other Products & Services

A broad range of other services are offered by Bionique® to include: mycoplasmastasis, custom mycoplasma antigen preparation, consultancy and training, contract research and development, and validation studies.

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Specializing In

Real-Time PCR Testing

Bionique has optimized the MycoSEQ Real-Time PCR Detection Assay for mycoplasma testing.

PCR Testing Services Harmonized USP Testing