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Bioassay Development

We develop assays for microbial and mammalian protein systems, cell therapies, and viral vector substances. 

Whether you’re starting from scratch, have a partially developed method, or are transferring to a fully developed method for validation; we reliably design, troubleshoot, and develop a method for standardized cGMP release of validated results — backed by the statistical power you need.

Bioassay development capabilities include: 

  • Molecular Bioassay Development
  • Quantitative ELISAs for titer determination
  • Potency testing for ELISAs (in direct-binding or competition format), Cell Therapy drug substances
  • Biacore
  • Enzyme assays
  • Mycoplasma PCR (Cell Therapy)
  • Cellular Bioassay Development
    • proliferation, viability, signal transduction, apoptosis, reporter gene assays, and CDC assays

    • Ability to create release-ready cell banks

  • RCL Molecular assay for cell therapy (a part of a comprehensive QC testing panel)
  • Transgene functional assay (a part of a comprehensive QC testing panel)
  • Transgene-client-specific Assays for vector products
  • Replication competent AAV (RC-AAV) assay

 

Interested in learning more?

Contact our team