Animal product free system and process for purifying a

1. An animal protein free (“APF”) process for purifying a biologically active botulinum toxin, the process comprising the steps of:

(a) obtaining a sample of a botulinum toxin fermentation culture, wherein the botulinum toxin fermentation culture results from a substantially APF process,

(b) contacting a hydrophobic interaction chromatography column resin with the culture sample so as to permit capture of a botulinum toxin by the hydrophobic interaction chromatography column;

(c) washing impurities off the hydrophobic interaction chromatography column;

(d) eluting the botulinum toxin from the hydrophobic interaction column;

(e) loading an ion exchange column chromatography column resin with the eluent from the hydrophobic interaction chromatography column;

(f) washing impurities off the ion exchange chromatography column, and;

(g) eluting the botulinum toxin from the ion exchange column, thereby obtaining a purified biologically active botulinum toxin through a process for purifying a botulinum toxin which is a substantially APF purification process.

2. The APF process of claim 1 , further comprising, after the step of obtaining a sample of a botulinum toxin fermentation culture and before the step of contacting a hydrophobic interaction chromatography column resin with the culture sample, the step of conditioning the clarified culture for hydrophobic interaction chromatography.

3. The APF process of claim 1 , further comprising, after the step of eluting the botulinum toxin from the hydrophobic interaction column and before the step of loading an ion exchange column chromatography column resin with the eluent from the hydrophobic interaction chromatography column, the step of conditioning the eluent from hydrophobic interaction column for ion exchange chromatography.

4. The process of claim 1 , wherein the botulinum toxin is a botulinum toxin type A, B, C, D, F, F or G.

5. The process of claim 1 , wherein the botulinum toxin is a botulinum toxin type A.

6. An APF process for purifying a biologically active botulinum toxin, the process comprising the steps of:

(a) obtaining a sample of a botulinum toxin fermentation culture, wherein the botulinum toxin fermentation culture results from a substantially APF process,

(b) conditioning the clarified culture for hydrophobic interaction chromatography;

(c) contacting a hydrophobic interaction chromatography column resin with the culture sample so as to permit capture of a botulinum toxin by the hydrophobic interaction chromatography column;

(d) washing impurities off the hydrophobic interaction chromatography column;

(e) eluting the botulinum toxin from the hydrophobic interaction column;

(f) conditioning the eluent from hydrophobic interaction column for ion exchange chromatography;

(g) loading an ion exchange column chromatography column resin with the conditioned eluent from the hydrophobic interaction chromatography column;

(h) washing impurities off the ion exchange chromatography column, and

(i) eluting the botulinum toxin from the ion exchange column, thereby obtaining a purified biologically active botulinum toxin through a process for purifying a botulinum toxin which is a substantially APF purification process.

7. The process of claim 6 , wherein the botulinum toxin is a botulinum toxin type A, B, C, D, F, F or G.

8. The process of claim 6 , wherein the botulinum toxin is a botulinum toxin type A.