Process and system for obtaining botulinum neurotoxin

摘要

Rapid, animal protein free, chromatographic processes and systems for obtaining high potency, high yield botulinum neurotoxin for research, therapeutic and cosmetic use.

主权项

1. An animal product free (APF) process for obtaining a botulinum neurotoxin, the process comprising the following steps:
(a) providing an APF fermentation medium; (b) fermenting clostridium botulinum bacteria in the fermentation medium, wherein the clostridium botulinum bacteria produce a botulinum neurotoxin, and; (c) performing a first contacting step wherein the fermentation medium containing the botulinum neurotoxin is contacted with an anion exchange chromatography medium; (d) eluting the captured botulinum neurotoxin from the anion exchange medium to obtain a first eluate; (e) performing a second contacting step in which the first eluate is contacted with a cation exchange chromatography medium to obtain a second eluate; (f) contacting the second eluate with a hydrophobic interaction chromatography medium; and (g) eluting a third eluate from the hydrophobic interaction chromatography medium;thereby obtaining the botulinum neurotoxin.