PROCESS FOR PRODUCING RECOMBINANT HUMAN SERUM ALBUMIN IN PICHIA PASTORIS BY A NOVEL GENE AND ITS PHARMACEUTICAL USES

摘要

A process for preparation and purification of a recombinant human serum albumin and a novel clone thereof, which comprises of: Culturing of recombinant Pichia pastoris in complex / defined medium to build up high cell mass. Culturing of recombinant Pichia pastoris in complex / defined medium to produce human serum albumin protein. Culturing of recombinant Pichia pastoris in charcoal containing complex media to produce human serum albumin protein of therapeutically acceptable quality and color. Culturing of recombinant Pichia pastoris in a two step fermentation process. Purification of recombinant human serum albumin (r-HSA) from fermentation broth of above mentioned recombinant Pichia pastoris. Formulation of purified r-HSA with various pharmaceutically accepted ingredients. Use of the r-HSA for various medical purposes.