What are Botulinum Toxins?
Botulinum toxins are produced by the bacterium Clostridium botulinum and are perhaps the most poisonous natural toxins known. Ingestion of the toxin results in rapid neurotoxicity, leading to paralysis through disruption of neuronal function. Interestingly, the toxin’s paralytic action is being exploited for cosmetic and therapeutic applications. The toxin can be delivered safely in very small doses to treat a variety of conditions including Crow’s Lines, involuntary eye muscle contractions (blepharospasm), cervical dystonia, and migraines. Current unlicensed indications include low back pain, Parkinson’s disease, and chronic anal fissures.
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.