Large scale chromatographic purification of alpha 1-antitrypsin from human plasma supernatant II + III.

We describe a large-scale chromatographic method to purify alpha 1-antitrypsin (AAT) from human plasma supernatant II + III. Supernatant II + III was injected onto DEAE sepharose CL 6B to get an albumin-rich fraction as well as a fraction that contained about 45% AAT. This intermediate purity AAT fraction was further purified by size-exclusion chromatography on Sephacryl S-200. The product was heated in solution at 60 degrees C for 10 hours in the presence of a stabilizer to lower the risk of transmission of viral diseases. Purity of the AAT concentrate is over 85%; clinical testing of its safety and efficacy in the treatment of PiZ patients is underway.