PROCESS AND SYSTEM FOR OBTAINING BOTULINUM NEUROTOXIN

Abstract

A substantially animal-protein free (APF) composition comprises a botulinum toxin serotype A neurotoxin having a molecular weight of 150 kDa, comprising one nanogram or less of residual nucleic acid for each milligram of the botulinum neurotoxin component, wherein the botulinum toxin serotype A neurotoxin is obtainable by a process comprising the steps of (a) providing a substantially APF fermentation medium; (b) fermenting Clostridium botulinum bacteria in the fermentation medium, and; (c) recovering the biologically active botulinum neurotoxin from the fermentation medium by contacting the fermentation medium with an anion exchange chromatography media followed by contacting an eluent from the anion exchange chromatography medium with a cation exchange chromatography media.

Inventors

TON, JENNIFER L.
PATEL, HEMANT A.
BATES, RONALD C.
AHMAD, WAJDIE M.

Assignees

Allergan, Inc.

Dates

Publication Date: 20260513
Application Date: 20100712