Microbial control and remediation of Protein A chromatography resin

Affinity capture chromatography continues to be a primary choice for the initial purification of mAbs and Fc-containing fusion peptides. This is due to the scalability of development to commercial processes and the efficient removal of process and product-related impurities. However, despite the depth of process characterization and widespread use of affinity chromatography, there are some challenges for the microbiological management of the unit operation. To investigate this area, our new paper identifies the strategies for remediating bioburden-impacted Protein A resins. It considers the challenges around contamination and investigates the preventative microbial control of chromatography resin and resin remediation strategies. The experience presented in the paper can be distilled into three salient factors, each of which is necessary to remediate bioburden from Protein A resins: Potency (of sanitizing agent) Contact (between target organisms and sanitizing agent) Time (duration of contact between target organisms and sanitizing agent). Several member companies have reported the successful remediation of Gram-positive spore-forming bioburden from Protein A resin using peracetic acid. Using acid-based or oxidizing chemistry to remediate biological contaminants in Protein A resins may offer advantages over traditional caustic-based approaches. These benefits include a reduced impact on the resin’s static and dynamic binding capacities, as well as fewer treatments required to achieve satisfactory clearance of the contaminating species.