Manufacturing and Clinical Formulations of Botulinum Neurotoxins.

Abstract

Botulinum Neurotoxins have always existed in nature, but its paralytic effect on humans due to the consumption of poorly preserved food was not recognized until 18th century. There are 8 serotypes of botulinum neurotoxins (A, B, C, D, E, F, G, H). Serotype A have been the most recognized one and was initially developed for large scale production in 1940's. The first batch for clinical use was produced by Edward Schantz, who collaborated with Dr. Alan Scott, an ophthalmologist, evaluating botulinum neurotoxin to treat strabismus. The process Schantz used had variability and led to inconsistent batch production. However, this process is still used by various manufacturers of commercial botulinum neurotoxin products as the foundation. These manufacturers have refined the manufacturing of botulinum neurotoxins by implementing new advanced techniques, including better potency assays. Despite the improvements in the manufacturing process, botulinum neurotoxins are still one of the most potent molecules and therefore, require special handing and additional safety/security measurements during production.