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Toll Free 1.800.756.5658

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info@bioreliance.com

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Potency and Bioassays

Potency assays are essential in verifying product quality; it is critical to choose a testing partner that understands your development needs. FDA and EMA guidelines mandate that customized potency assays be developed and validated prior to clinical trials. This testing is commonly done through in vivo or in vitro bioassays, as advised by global regulatory agencies, to demonstrate product efficacy and manufacturing consistency.

We work with you to design custom cell-based assays that are regulatory compliant, reliable, and relevant to your specific biologic. With years of experience in assay development, validation, and transfer, we offer considerable knowledge for support of clinical trials as well as lot release and stability testing programs. Our expertise encompasses the development of functional and ligand binding bioassays, including:

  • ADCC
  • CDC
  • In vitro mechanism of action
  • ADCP Activity
  • Reporter assays

Additional biological assays:

  • Abnormal toxicity
  • Endotoxin testing
  • Extractable volume measurement
  • Host cell DNA analysis
  • Host cell protein analysis
  • Infectivity titer determination
  • Phenol red content analysis
  • Polymerase chain reaction (PCR) analysis of DNA contaminants
  • Polysorbate 80 analysis
  • Process component contaminant analysis
  • Restriction enzyme DNA mapping
  • Sterility testing

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