Antibody Therapeutic Polishing

The ultimate goal of downstream purification is to reliably and predictably produce a safe drug product suitable for therapeutic use in humans. To this end, biomanufacturing process- and product-related impurities such as host cell proteins (HCPs), residual DNA, leached protein A, process leachables and extractables, adventitious and endogenous viruses, endotoxins, antibody aggregates, and other antibody variants all must be removed to acceptable levels in conformance with regulatory guidelines.

This eBook describes a family of POROS HIC resins with novel ethyl and benzyl chemistries for the successful polish of two challenging MAb drug products, both with high levels of aggregates (>10%). In addition to aggregate clearance, viral clearance strategies for these model MAb processes are discussed extensively, including a predictive technique that uses parvovirus surrogate mock virus particles (MVPs) from MockV Solutions as well as live viral clearance data using xenotropic murine leukemia virus (XmuLV) and minute virus of mice (MVM).

The authors show how optimizing important process parameters can improve process efficiency and productivity. They demonstrate how POROS HIC resins can be used as a powerful tool to simplify MAb purification schemes and improve process throughput.