Botulism Antitoxin Heptavalent (BAT)

The manufacturing process for each antitoxin type includes cation-exchange chromatography to purify the immune globulin fraction, digestion with pepsin to produce F(ab`)2 and F(ab`)2-related immune globulin fragments, anion exchange chromatography to remove the pepsin as well as other impurities and filtration. In addition, the manufacturing process includes two viral inactivation/removal steps; solvent/detergent (S/D) treatment and virus filtration (Table 5).The S/D treatment step is effective at inactivating known lipid-enveloped viruses such as equine encephalitis, equine arteritis, West Nile virus, equine infectious anemia, equine herpes virus, rabies, and equine influenza. The BAT manufacturing process also includes a robust virus filtration step which removes viruses based on size. The virus filtration step is therefore effective for all the above lipid-enveloped viruses as well as smaller non-enveloped viruses including equine rhinovirus, equine adenoviruses and adeno-associated viruses, and equine parvovirus.The product potency is expressed in units based on the mouse neutralization assay (MNA). Each unit of BAT is designed to neutralize 10,000 mouse intraperitoneal lethal dose 50% units (MIPLD50) of botulinum neurotoxin for serotype A, B, C, D, F, and G and 1,000 MIPLD50 of serotype E.BAT is formulated with 10% maltose and 0.03% polysorbate 80. The formulated bulk material contains approximately 3 to 7 g% [30 to 70 milligrams/milliliter (mg/mL)] protein (Sectio