PROCESS OF HIGH PURITY ALBUMIN PRODUCTION

摘要

A process is provided for the preparation of albumin which has extremely low levels of or is essentially free of colorants, metal ions, human proteins, host proteins, fragments of albumin, polymers or aggregates of albumin and viruses, and which is essentially non-glycated, relatively high in free thio l and with an intact C-terminus. The process comprises passing albumin (preferably expressed and secreted by transformed yeast) through positive mo de cation exchange and then positive mode anion exchange chromatography. Other steps may also be employed, for example ultrafiltration, gel permeation chromatography, affinity chromatography binding the albumin (for example usi ng blue dyes) and affinity chromatography binding contaminants (for example usi ng an aminophenylboronic acid resin). Elution of albumin, with a compound havin g affinity for albumin, from a material having no specific affinity for albumi n is also disclosed, as is removal of ammonium ions with a counter-ion.