Aaron Moulin, Field Application Specialist at Purolite, explores the need for a straightforward, quality-by-design (QbD) led approach to switching chromatography resin suppliers so that when new antibody types are developed, novel purification challenges can be overcome.
Chromatography is a crucial component of downstream processing, removing or reducing contaminants to acceptable levels and achieving a highly pure end product. For monoclonal antibody (mAb) therapies, Protein A affinity chromatography is typically employed as a critical step in purification, with the target molecule generally eluted under acidic conditions, between pH 3 and 3.5. As antibody-based therapies continue to progress and antibody properties become increasingly diverse and complex, a wider operational window for elution is sometimes necessary to maintain high yields. Access to alternative Protein A resins that allow for elution at higher pH levels can maintain high yields and retain the use of a classic Protein A and Ion Exchange mAb purification. However, established Regulatory frameworks and best practices for optimal evaluation and selection of alternative Protein A resins are lacking.