METHOD FOR PRODUCTION OF A THERAPEUTICALLY PURE GRANULOCYTE MACROPHAGE - COLONY STIMULATING FACTOR

摘要

A simple and scaleable process is provided for obtaining recombinant human GM CSF expressed in microbial cells, secreting mature GM-CSF, culturing these cells and purifying the protein in good yield and of a therapeutic grade quality. The steps include cloning, fermentation and purification of the protein. The purified protein is got by a process that involves lysing the microorganism, extraction of the processed and unprocessed forms of GM-CSF from the membrane pellet and selectively purifying the processed form of the protein from the unprocessed form by a two-step chromatography procedure. The purity of the processed form of GM-CSF (without signal peptide) obtained has endotoxin units, host cell proteins and host cell DNA within the specified compendial limits for therapeutic proteins.