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Botulinum Toxin and Insulin Identity and Potency

Pacific BioLabs has extensive experience in performing cgmp bioassays, including botulinum toxin identity and potency testing. Toxin testing is conducted in full compliance with CDC regulations and guidelines, and Pacific BioLabs is recognized as a leader in this space.

In addition, Pacific BioLabs has extensive experience in performing assessments of Insulin. For over 15 years, PBL has performed insulin bioassays including both biopotency and bioidentity tests according to USP <121>.

Available In Vivo Bioassays:

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

Glucagon and Tetracosactide Assessment Services

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.

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.

Available In Vitro Bioassays:

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

Details of Botulinum Potency Testing

Every therapeutic preparation of botulinum toxin is required by the FDA to be tested for potency and stability during the production process. This testing is required to determine if the product is suitable for release to the clinic. Both the active pharmaceutical ingredient (Drug Substance) and the final formulated product (Drug Product) must be tested for potency and stability.    

In addition to stability and potency testing, patients treated with botulinum toxin may develop antibodies that make the toxin ineffective. Clinicians need to verify if the patient has produced antibodies to botulinum toxin in order to determine if a patient will respond to treatment. The assay uses patient serum mixed with toxin. If the patient has developed antibodies to the toxin, the toxin's effect will be decreased. If the patient does not have antibodies to the toxin, the toxin will remain fully active.

Pacific BioLabs has a dedicated staff with expertise in toxin testing for stability and potency determinations of drug substance and drug product. PBL staff can also test patients' serum for the presence of anti-botulinum toxin antibodies. Experienced study directors and technical staff can assist in the design and execution of studies, and provide a rapid turnaround time for results. 

Intertek Logo PBL is FDA registered and ISO 9001:2008 and ISO 13485:2003 certified by Intertek. AAALAC Logo Our animal science operations are accredited by AAALAC.

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