Platform Analytical Approaches Enabling Expedited Development of a Therapeutic mAb Product
Presented by Laura Bass, Pfizer, Inc.
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 Pfizer Biotherapeutics portfolio includes 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 without compromising 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 and streamlined work processes have enabled the rapid advancement of our monoclonal antibody therapeutics without compromising product integrity. This presentation will describe our mAb platform analytical approach towards methods development, methods qualification, and product characterization. In addition, the work processes and matrixed organizational structure that facilitated the rapid advancement of Pfizer’s mAb portfolio will be described.
Who Should Attend this Program: If you are working in the areas of biopharmaceutical development, separations sciences, or regulatory sciences this program is for you!
Learning Objectives: If you are interested in learning about an array of analytical techniques and associated CMC strategies applied to rapidly advance therapeutic mAb products, please attend this discussion group. Approaches to instituting platform analytical methods such as SE-HPLC for aggregates, CGE for fragments, RP-HPLC for disulfide isomers, and iCE/CEX for charge-variants will be discussed. In addition, an overview of approaches to platform method qualifications and specifications will also be provided.