Galderma Holding Sa

Ipsen Biopharm Limited

Nestle Skin Health Sa

Anders Jarstad

Ulf Stahl

Ann Gurell

Lena Nodqvist

Simon Aberg

Sebastiaan Mul

Emilia Edstrom

John Nolin

Anna Friis

Andrew Pickett

Barbro Agren

Peter Frank

The present technology relates to commercial-scale methods for purifying botulinum toxin compositions obtained from cell cultures. Purification methods according to the present disclosure are based on a series of filtration and chromatographic separation steps that produce a high-purity botulinum toxin composition, which comprises botulinum toxin protein molecules (˜150 kDa) in solution, which is free, essentially free, or substantially free of botulinum toxin complexes and animal products, and without precipitating or lyophilizing botulinum toxin protein molecules. The purification method according to the present disclosure uses no precipitation, lyophilization, or centrifugation steps, permitting production of highly pure, highly active, free botulinum toxin protein molecules (˜150 kDa) in solution, without the need for reconstitution by the end user.

Method of purifying botulinum toxin

The invention relates to stable liquid neurotoxin formulations which are free of animal proteins, comprising a surfactant, an amino acid selected from tryptophan and tyrosine, a buffer comprising sodium, chloride and phosphate ions, which have a pH between 5.5 and 8, and which are stable for 2 months. These compositions are suitable for use in therapy and in particular for administration to a patient to achieve a desired therapeutic or aesthetic effect. The invention also relates to the use of an amino acid selected from tryptophan and tyrosine to protect a proteinaceous neurotoxin from degradation in a liquid composition which is free of animal derived proteins.

Liquid neurotoxin formulation stabilized with tryptophan or tyrosine

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Uppsala, Sweden

Anders Jarstad