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BIOASSAYS

Pacific BioLabs has extensive experience in performing bioassays, including procedures to assess the safety of therapeutic toxins. Toxin testing is conducted in full compliance with CDC regulations and guidelines.

Glucagon is a critical drug for the treatment of diabetes. The glucagon potency assay is a challenging ex vivo procedure using a primary culture of rat hepatocyte cells. PBL is perhaps the only independent laboratory in the world offering this assay.

For over 15 years, PBL has performed insulin biopotency and bioidentity tests according to USP <121> . We have also developed a bioassay for tetracosactide. This test is used to determine the potency of a tetracosactide preparation compared to a calibrated World Health Organization (WHO) reference standard.

In Vivo Bioassays:

• Botulinum Toxin
  • Potency
  • Identity/Safety testing
  • Mouse Protection Assay (patient antibody testing)
• Insulin (USP)
  • Biopotency (quantitavie)
  • Bioidentity (qualitative)
• Somatotropin (USP)

In Vitro Bioassays:

• Tetracosactide (USP) - Potency
• Glucagon (USP) - Potency