Analytical Strategies Enabling Expedited Development of Therapuetic mAbs

A common challenge faced in biopharma is the ability to advance numerous projects throughout development while minimizing cost and timelines and maximizing the robustness of the CMC strategy. The portfolios at many biotech companies include multiple therapeutic monoclonal antibodies (mAbs) along with several other therapeutic modalities in development. With the number of monoclonal antibody programs increasing and rapidly advancing through development, it is imperative to apply state-of-the-art analytics and to implement streamlined/efficient work processes while maintaining product quality and safety. At Pfizer we have implemented a platform analytical approach to rapidly advance our therapeutic mAb programs. This analytical approach monopolizes on the structural homology across mAbs yet provides modular options to address mAbs with unique characteristics. State-of-the-art analytics (e.g. Ultrahigh-resolution ESI-QTOF mass spectrometry to confirm sequence fidelity during clone selection) and streamlined work processes have enabled the rapid advancement of our monoclonal antibody therapeutics. This presentation will describe our mAb platform analytical approach and organizational work process towards methods development, methods qualification, and product characterization to facilitate the rapid advancement of mAb therapeutics in the portfolio.