Next-generation, high-capacity, alkali-stable protein A resins have recently become available in anticipation of increased production and throughput demand for protein therapeutic processes. Efficient caustic cleaning and bioburden control regimens have allowed agarose-based, alkali-stable protein A chromatography resins to become the backbone of many commercial purification processes for over a decade and have served as the primary capture step for monoclonal antibody (MAb) purification processes. However, the relatively high raw material costs, along with limitations to binding capacity and aggressive resin…
Author Archives: Tony Hong
Performance of a Salt-Tolerant Membrane Adsorber in Flow-Through Mode
Monoclonal antibodies (MAbs) have become the most prevalent therapeutics in the biopharmaceutical industry. Their downstream purification typically involves protein A chromatography as a capture step followed by one or two additional chromatographic polishing steps. Additional unit operations dedicated specifically for viral clearance (e.g., viral inactivation and filtration) are added to ensure product safety. According to a survey of Amgen processes, after processing through a protein A column, only trace amounts of impurities such as Chinese hamster ovary cell protein (CHOP)…