Safe, stable, and effective biopharmaceuticals require an in-depth understanding of biophysical, biochemical, and bio-functional attributes as well as the correlation between these properties. To advance products through phases of development, from candidate selection to commercial manufacturing, product characterization must evolve to inform refined process development that facilitates the manufacturing of products with sufficient control over safety, efficacy, purity, quality, and strength.
There is an ever-growing diversity of new modalities in biopharmaceuticals such as multi-specifics, ADCs, mRNA, and nanoparticle modalities. Along with this expansion of therapeutic modalities and novel mechanisms of action, the characterization of such products accordingly requires unique strategies – new techniques or new approaches using existing techniques. This session aims to discuss product understanding of novel modalities along with the challenges in establishing the appropriate and biologically-relevant critical quality attributes that is the foundation of the control strategy for these new products.
13:50 - 14:15 Characterization of Novel Biological Product Modalities: A Regulatory Perspective Leslie Rivera Rosado, CDER, FDA 14:15 - 14:40 Characterization of mRNA Fragments to Evaluate Risk of Truncated or Off-Target Antigen Expression Thomas Lerch, Pfizer, Inc. 14:40 - 15:05 Process Development Challenges for Bi-specific/Multi-specific Drug Development Twinkle Christian, Amgen Inc.