Bionique Testing Laboratories, Inc. is a mycoplasma test facility, specializing in the detection of mycoplasma contamination in cell cultures and related cell culture products. The company has provided mycoplasma testing services to the scientific community since 1983. Bionique® Testing Laboratories, Inc. plays a critical role in the success of our clients by assuring the integrity and biosafety of their cell cultures and final product.

Purpose and Mission

Bionique Testing Laboratories, Inc. will provide to all our clients the best possible mycoplasma testing products and services available to meet each client's individual biosafety needs and standards. Through a unique combination of experience, expertise and focus, we are able to provide unparalleled quality assurance and services.

• Proven leader with over 20 years of experience in the testing of cell cultures and biologicals for mycoplasmal contamination
• Expert technical support team available to meet your scientific and regulatory needs
• cGMP compliant facility.

Examples of Submitted Product Samples:

• Primary and Continuous Cell Cultures
• Hybridomas
• Monoclonals
• Polyclonals
• Master Cell banks
• Working Cell Banks
• Final Products
• Bioreactors
• Media/Sera
• Growth Factors
• Biologicals
• Vaccines

Mycoplasma Test Products and Services:

• Direct Culture
• Indirect Assays by DNA fluorescence staining with Indicator Cell Line
• Antibiotic Sensitivities
• Validation Studies
• Mycoplasma Elimination
• Mycoplasma Diagnostic Kit
• Mycoplasma Control Slides
• Contractual R&D Services

Regulatory Compliance:

• Center of Biologics Evaluation and Research, FDA, Points to Consider in the Characterization of Cell Lines Used to Produce Biologics 1993.
• FDA 21 CFR 610.30

Confidentiality:

All client information including sample receipt, raw data and final reports are treated in strict confidence. Contractual confidentiality agreements are generated upon request.

Questions:

For information on mycoplasmal testing services appropriate for your sample and regulatory requirements, please contact technical services at (518) 891-2356 or via e-mail.

The American Society For Cell Biology
Dec 11-15,2010
Philadelphia Convention Center
Philadelphia, PA
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