Saccharomyces Specific- HCP Assay for r-PAI-2 Therapeutic Proteins.

Abstract

Whenever a host cell is employed for a means of propagation of recombinants, some impurities are bound to come across and they are invariably of host cell components and are part of final recombinant proteins. These are investigated for the first time in case of recombinant host, “yeast cells” Saccharomyces. With great care, high affinity antibodies are generated for yeast proteins using Gene-minus (null-cell) yeast components purified by down-stream techniques with appropriate resins for column purification and these antibodies are being used to construct specific sandwich ELISA system to monitor the degree of host contaminants proteins (HCPs). How this is being done and what strategic methods are followed and how the HCP- detection ELISA systems are constructed and what are the limitations?. These points are described and discussed along with prospects of HCPs in the intensified therapeutic proteins preparation. Our HCP assay is sensitive enough to detect 200-250 ppm in the final PAI-2 product.