Patent ID: 8324349

Claim:
A biologically active botulinum neurotoxin obtained utilizing a substantially APF chromatographic system, the system comprising: a first apparatus for culturing Clostridium botulinum bacteria, the first apparatus capable of containing a substantially APF culture medium; a second apparatus for fermenting Clostridium botulinum bacteria which have been cultured in the first apparatus, the second apparatus capable of containing a substantially APF fermentation medium; a third apparatus for harvesting the fermentation medium; a fourth apparatus for concentrating the harvested fermentation medium and diluting the filtered fermentation medium; a fifth apparatus for carrying out a first purification of the botulinum neurotoxin from the harvested medium, wherein the fifth apparatus comprises an anion exchange chromatography media, thereby obtaining a first purified botulinum neurotoxin; and a sixth apparatus for carrying out a second purification of the first purified botulinum neurotoxin wherein the sixth apparatus comprises a cation exchange chromatography media, thereby obtaining a second purified botulinum neurotoxin, wherein the botulinum neurotoxin obtained has a potency of at least about 2.0 times 10 7 units/mg of botulinum neurotoxin, the botulinum neurotoxin obtained comprises one ng or less than one ng of residual nucleic acid for each mg of the botulinum neurotoxin obtained and the process is carried out in one week or less.