Advancing multiproduct resin reuse for development and clinical manufacturing of an antibody-based therapeutic.

Chromatography resins used for purifying biopharmaceuticals are generally dedicated to a single product. For clinical manufacturing, this can result in resin being used only for a fraction of its potential lifetime. Extending the use of resins to multiple products can significantly reduce resin waste and cost.

A practical strategy for using miniature chromatography columns in a standardized high-throughput workflow for purification development of monoclonal antibodies.

The emergence of monoclonal antibody (mAb) therapies has created a need for faster and more efficient bioprocess development strategies in order to meet timeline and material demands. In this work, a high-throughput process development (HTPD) strategy implementing several high-throughput chromatography purification techniques is described. Namely, batch incubations are used to scout feasible operating conditions, miniature columns are then used to determine separation of impurities, and, finally, a limited number of lab scale columns are tested to confirm the conditions identified using high-throughput techniques and to provide a path toward large scale processing.