PROCESS, MEDIUM AND CELL CULTURE SYSTEM FOR THE PREPARATION OF RECOMBINANT FACTOR VIII IN A PROTEIN FREE MEDIUM

摘要

The present invention provides methods for recombinant VIII. factor VIII. in mammalian cells carrying the factor I gene, cultured in a medium free of plasma-derived proteins such as albumin, containing polyols and resions. The medium preferably also contains other trace metals. In a highly preferred embodiment of the invention, the medium comprises polyglycol known as Pluronic F-68, copper sulphate, iron sulphate-EDTA complex and salts of trace metals such as manganese, molybdenum, silicon, lithium and / or chromium. The invention further relates to plasma-free protein-free media containing polyols and resions and preferred trace metals for use in the method of the invention. Recombinant VIII. due to the lack of proteins from plasma, essentially without the risk of viral input.