Daewoong Co., Ltd.

Chung Sei Kim

Kyoung-Yun Kim

Hye-Young Sul

Kwan Young Song

Kyoung Min Min

Yeong Duk An

Myung Seob Kim

The present invention relates to a method for producing a botulinum toxin comprising: (a) treating a culture of a botulinum toxin-producing strain with acid to form a botulinum toxin-containing precipitate; (b) adding a buffer to the botulinum toxin-containing precipitate of step (a), followed by clarification by at least one method selected from the group consisting of depth filtration (DF), microfiltration (MF), ultrafiltration (UF), sterile filtration, membrane chromatography (MC) and centrifugation; (c) subjecting the botulinum toxin-containing solution of step (b) to UF diafiltration, ammonium sulfate precipitation or hydrochloric acid precipitation, and then diluting a retentate resulting from the UF diafiltration in a buffer or dissolving a precipitate resulting from the ammonium sulfate precipitation or hydrochloric acid precipitate in a buffer; and (d) subjecting the retentate dilution, ammonium sulfate precipitate solution or hydrochloric acid precipitate solution of step (c) to anion-exchange chromatography (AEX) to purify the botulinum toxin.

Method and producing botulinum toxin

A method of making botulinum toxin comprises treating a culture of a botulinum toxin-producing strain with acid to precipitate a botulinum toxin; adding buffer to the precipitated botulinum toxin, followed by treatment with a protease inhibitor and nuclease, thereby extracting the botulinum toxin; treating the extracted botulinum toxin with acid to precipitate the botulinum toxin and dissolving the precipitate in buffer; and purifying the botulinum toxin by anion exchange chromatography. The use of the method makes it possible to produce a high-purity botulinum toxin by a simple process. The botulinum toxin produced by the method has high purity, and thus has an increased ability to act in a local area. Thus, the systemic circulation of the botulinum toxin is reduced to increase the safety. Accordingly, the botulinum toxin can be used for treatment of neuromuscular disorders, removal of wrinkles, and treatment of spastic hemiplegia and cerebral palsy.

Method for production of botulinum toxin

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Seoul, South Korea

Chung Sei Kim