Application of Platform Approaches to the Development of Bispecific Antibodies

Finding the Perfect Balance Between Speed and Quality in Bispecific Antibody Production

While monoclonal antibodies (mAbs) readily fit platform approaches to purification and product quality analytics, the variable physicochemical properties of bispecific mAbs (BsAbs) mean that they are prone to fragmentation, formation of homodimers and aggregation. These challenges, coupled with low titer and yield, can ultimately lead to more extensive processes and analytical development when compared to mAbs.

However, provided that the chosen CDMO partner possesses the technical expertise and experience, and based on an evaluation of the molecule’s personality, particularly in cases where the BsAb molecule behaves very similarly to a mAb, the application of platform approaches to the development of bispecific antibodies should be considered. If proven to be viable, such approaches could yield benefits to the client in the form of an accelerated production timeline that encompasses comprehensive product quality assessments.