Bispecific monoclonal antibodies (bsAb) offer enhanced therapeutic efficacy over traditional monoclonal antibodies (mAb), but present unique analytical challenges related to their design and manufacturing strategy. As bispecifics production processes evolve, process development and comprehensive characterization studies are necessary to increase understanding and deliver a robust manufacturing process with desired product quality. Developing robust analytical methods is critical in the identification and quantitation of critical quality attributes and ensuring process consistency.<br/> <br/>For bispecifics, the variety of unique manufacturing process brings challenges in the development of analytical methods not only to monitor the assembly process, but to subsequently separate the bispecific molecule from undesired impurities. For some bispecific molecules, the molecule assembly and subsequent removal of residual homodimer require sensitive and robust analytical methods to both quantify complete bsAb formation and to assess final bsAb purity.<br/> <br/>In this work, we have evaluated a new HPLC Method Scouting System and Simulation Software in the development of analytical methods for bispecific molecules. Specifically, we have developed a rapid RP-HPLC in-process monitoring test for profiling the bispecific antibody and its potential fragments after manufacturing process assembly. This presentation will highlight the complete analytical design evaluation of the scouting system and simulation software in the development of analytical methods for profiling partially formed bispecific molecules. Advantages and limitations of both traditional and scouting HPLC systems will be discussed.

How fast can we go? HPLC scouting system for accelerated method development of bispecific antibodies

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.