Increased Viral Clearance in Downstream Process Manufacturing Through Use of Novel Purification Resins and Additives

Downstream processing of monoclonal antibodies, which involves multiple chromatographic purification, buffer exchange, and viral inactivation steps, remains the major bottleneck in the manufacturing of these biologic molecules. The evaluation and selection of proper materials and reagents during process development is crucial in developing and optimizing a robust purification process that ensures that in-process impurities from upstream production are removed.

In this presentation, we will discuss the development of a novel affinity chromatography resin, PROchievA^TM. We will show that PROchievA^TM provides enhanced purification of monoclonal antibodies and when used in combination with select additives, enhances the removal of impurities such as host cell protein, DNA, and viruses. Furthermore, we will show how PROchievA^TM provides increased purification of Fc-fusion proteins, and when properly utilized in conjunction with subsequent downstream purification steps, can lead to improvement in overall manufacturing process efficiency of mAbs.

This presentation was given during BPI Europe, Vienna, May 17-19, 2022.