Rockland Immunochemicals, Inc. has announced the release of Host Cell Protein (HCP) antibodies that detect high, medium and low molecular weight proteins. Host Cell Proteins are process-related impurities derived from a host cell expression system that may be present in trace amounts in a final drug substance. HCP antibodies are used to detect impurities in biologically-based therapeutics. Assays are further developed using custom-manufactured process specific antibodies.
Rockland’s new HCP antibodies will be released and a standardized HCP immunoassay development process presented during the Well Characterized Biotechnology Pharmaceuticals (WCBP) Symposium in Washington, DC January 29-31. This United States Food and Drug Administration (FDA) co-sponsored symposium is the pre-eminent conference addressing the analytical development/regulatory control interface for biotechnology derived health intervention products.
The FDA requires that pharmaceutical and biotechnology companies producing therapeutic antibodies minimize HCP contamination to an acceptable level. Failure to identify and sufficiently remove contaminants early in drug development can result in reduced drug efficacy or adverse toxic or immunological reactions in patients.
ELISA, the most widely used assay for determining the presence of HCPs, uses a polyclonal antibody mixture raised against host cell proteins. The accepted workflow for evaluating the immunocoverage of HCP antibodies involves 2-D gel electrophoresis followed by Western blotting. Rockland now provides Bioprocessing researchers with antibodies and custom HCP assay development services that streamlines and regulates this workflow.
At the WCBP Symposium, Rockland researchers will present data that shows an improved standardized immunoassay development process for HCP detection using 2D electrophoresis and western blotting. In collaboration with Bio-Rad, the PROTEAN® i12™ IEF System was used to develop the HCP antibodies and measure/calibrate assays. Detecting impurities often unseen by 1-D electrophoresis, this system delivers more complete insight into the immunocoverage of protein components of the host cell lysate. The newly developed Rockland antibodies have been fully evaluated using the 2-D electrophoresis workflow and provide efficient immunocoverage of E.coli HCP.
“Rockland’s expertise in HCP antibodies and HCP assay development services has allowed Bio-Rad to affirm the value of optimized IEF separations in generating a robust 2D-electrophoresis based assay for evaluating anti-HCP antibodies, ” said Sricharan Bandhakavi, Senior Scientist at Bio-Rad Laboratories.
"Over the last decade, BioPharma has invested significant amounts of money to develop large molecule (antibody) drugs. As these drugs move forward in the approval process, reagents and assays used to analyze purity will increase in importance,” commented Jim Fendrick, President and CEO of Rockland Immunochemicals. “With our well-developed antibody and assay technology, Rockland is well positioned to take advantage of this opportunity and set the standard for optimal quality of application."