With increasing mAb titers, the impurity level of the cell culture feed increases. If not removed, these impurities can build up on the protein A resin and start to leach into the process material in subsequent cycles. The presence of cell culture nutrients in the harvest feed loaded on the capture column also exposes the protein A step to increased risk of microbial contamination. Historically, protein A resins have been less chemical resistant to high concentrations of sodium hydroxide (NaOH), the commonly used cleaning and sanitization agent in bioprocessing. In this application note, resistance to high concentrations of NaOH is evaluated in protein A chromatography resins.
May 24, 2018