Comparative Biosciences, Inc. (CBI), a premier preclinical Contract Research Organization (CRO), conducts research studies in the area of toxicology, pharmacokinetics, efficacy, histology and immunohistochemistry with therapeutic botulinum toxin products. CBI also works with therapeutic antibodies designed to treat or reverse botulinum toxicity for example in a military enviroment.
Immunofluorescent section stained with Α-bungarotoxin demonstrating neurite sprouting in mouse administered botulinum toxin
Our scientific and technical staff is versed in the conduct of efficacy, mortality and toxicity studies using botulinum-based test articles for a variety of therapeutic indications and a variety of animal pharmacology models. Indications might include cervical dystonia, cross eyes, wrinkles, migraine headache, or urinary tract abnormalities.
Likewise and conversely, we are also experienced in animal models designed to test the activity of anti-botulinum test articles designed to cure botulinum poisoning as might occur during biological warfare or accident.
Toxicology: GLP and nonGLP toxicology studies in mice and more advanced species with particular emphasis on toxicity, reversibility of injury to the neuromuscular junction via clinical tests such as the Digital Abduction Test, and immunohistochemisty of the endplates. Studies may be single dose or multiple dose studies of longer duration.
LD50: LD50 studies in mice to determine potency.
Pharmacokinetic-Pharmacodynamic Studies: Dose-related responses, antibody formation, and other assessments.
Therapeutic Antibody Studies: Studies are designed to assess the ability of therapeutic antibodies, molecules, or vaccines designed to treat, revers, or cure botulinum toxicity.
Efficacy Studies: GLP and nonglp efficacy and efficacy-toxicity combination studies include assessment of systemic effects, toxicity, histopathology and immunohistochemistry of muscle and nerve, reversal by botulinum toxicity therapies such as therapeutic antibodies.
Histology and Immunohistochemistry: Assessment of local muscle injury and recovery via light microscopy and special stains. Immunohistochemical staining of neuromuscular endplates and neurons for morphological and functional injury and recovery, including, but not limited to alpha-bungarotoxin which binds to AChR moter end plate, VAChT, SV2, and synaptophysin which are proteins associated with the membrane of synaptic vesicles at the presynaptic nerve, and neurofilaments which are filament protiens found in neurons and their processes (nerve sprouts) at the presynaptic nerve.Read more about our specialized preparation, staining and assessment of muscle and nerves.