Botulinum Toxin (BoNT)
The use of natural products as novel therapeutics in medical and cosmetic indications has increased in recent years. One such product is Botulinum toxin, a protein produced by the bacterium Clostridium botulinum that is used to treat muscle spasms, chronic pain, hyperactive nerves, eye muscle disorders and other emerging therapeutic indications. Because of the toxicity of botulinum toxin, it is crucial for that the potency of the product is very accurately determined. Botulinum toxin use is highly regulated by both the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) given its potent biological mechanism of action.
Botulinum Toxin Bioassays
The gold standard for botulinum toxin potency testing is the in vivo mouse botulinum toxin bioassay. Since 1990, Pacific BioLabs has been working with botulinum toxin developing and offering a variety of in vivo and in vitro testing paradigms in support of research and clinical development efforts by private and commercial entities. PBL’s experience performing the in vivo mouse botulinum toxin bioassay is unmatched. Pacific BioLabs is registered, and works closely, with the Federal Select Agent Program at the CDC ensuring compliance with federal regulations associated with handling of botulinum toxin.
Pacific BioLabs has an experienced and dedicated staff with expertise in botulinum toxin testing offering the following assays:
- Botulinum Toxin Bioassay – In Vivo Lot Release Assay
- BoNT In Vivo Mouse Protection Assay – Patient Serum Testing
Botulinum Toxin Bioassay – In Vivo Potency Lot Release Assay
Each therapeutic preparation of botulinum toxin is required by the FDA to be tested for potency and stability before being released for use. A potency test ensure that all domains of the botulinum toxin protein are functional and that the biological activity of the entire molecule is within specifications. Pacific BioLabs supports testing of both the active pharmaceutical ingredient (Drug Substance) and the final formulated product (Drug Product) for potency and stability. Pacific BioLabs is registered with the CDC’s Federal Select Agent Program which means that we are capable of working with large amounts of botulinum toxin.
BoNT In Vivo Mouse Protection Assay – Patient Serum Testing
Patients undergoing treatment with botulinum toxin may develop antibodies that make the toxin ineffective, or less effective, against the indication for which they are being treated. Therefore, during clinical trials it may be important to determine if antibodies against the toxin are neutralizing the drug. Patient serum samples can be submitted by companies conducting a clinical trial to Pacific BioLabs for testing in an in vivo assay that will confirm the presence or absence of neutralizing antibodies to botulinum toxin. The botulinum toxin mouse protection assay may be used to support developmental activities, including ongoing clinical trials, and post market clinical surveillance programs.