Company Profile | May 24, 2007

Bionique Testing Laboratories, Inc. Testing Of Cell Cultures For Mycoplasmal Contamination

Source: Bionique Testing Laboratories, Inc.

Bionique Testing Laboratories is a mycoplasma testing facility specializing in the detection of mycoplasma contamination in cell substrates and cell-derived biologics. Bionique plays a critical role in the success of our clients by assuring the integrity and biosafety within their biopharmaceutical manufacturing processes.

Discover Bionique...
for high-quality Mycoplasma testing of your Cell Lines and Biotherapeutics.

Click Here To Download:
•Mycoplasma Testing Services Listing

For more information about Bionique, visit www.Bionique.com

Purpose and Mission

Bionique Testing Laboratories is committed to provide our clients with the highest quality mycoplasma testing services and products within our industry. 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 specializing in:

  • Cell Culture testing
  • Raw Material testing
  • Product Release testing
  • Validation Studies
  • Scientific and Regulatory Consultation

Mycoplasma Test Products and Services include:

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

Bionique Testing Laboratories can also provide clients with customized assays or services. Please contact our Technical Service department for further information.

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

Questions:

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