Adopting novel technologies to improve monoclonal antibody processes

As therapeutic monoclonal antibodies (mAbs) continue to dominate the biotherapeutics market, there is a growing demand for structurally diverse mAbs, namely bispecific antibodies. While mAbs can only bind to a single epitope, bispecific antibodies can bind two antigens at one time to kill cancer cells more efficiently.

Though extremely promising, this therapy does have a downside - bispecific antibodies are more challenging to manufacture as they are unstable, prone to aggregation and difficult to define due to mispairing of molecules. This instability can result in lower product yields, reduced therapeutic efficacy and patient immune reactions or complications.

Avantor’s Dr. Nandu Deorkar presents study results of four new-edge production technologies that better remove impurities, reduce aggregation and improve stability, including:

1. Detergent-based viral inactivation as an alternative to low pH treatment that overcomes environmental concerns
2. A newly designed chromatography ligand with high affinity for target antibodies
3. Additives in the wash step that enhance impurity clearance
4. Novel excipients in the formulation buffer to reduce protein-protein interaction

Read about new study data that show a final SEC purity of 99%, with overall process yield greater than 90%.