Optimizing Biologics Formulation Development

Keynote Presentations

9:10 NanoCrud: Roles of Nanoparticles in Aggregation Pathways, Adverse Immunogenicity and Quality Assessment of Therapeutic Proteins

John F. Carpenter, Ph.D., Professor, Pharmaceutical Sciences; Co-Director, Center for Pharmaceutical Biotechnology, University of Colorado Anschutz Medical Center

Recently, valuable new insights have been gained by characterizing nanoparticles in therapeutic protein products. For example, we found that nanoparticles present in solutions of intravenous immunoglobulin serve as precursors for microparticles during pharmaceutically relevant stresses (e.g., freeze-thawing or agitation). Also, therapeutic proteins can adsorb to foreign nanoparticles, and nanoparticles of therapeutic proteins can induce adverse immunogenicity. Regulatory agencies now view quantitation and sizing of nanoparticles as important for product quality assessment.

9:45 Strategies for Establishing a Formulation Function – A MacroGenics Case Study

Tom Spitznagel, Ph.D., Vice President, Development, MacroGenics, Inc.

This presentation will discuss some of the challenges in establishing a formulation department at a smaller company. Strategies for balancing risk tolerance, resourcing, outsourcing, and timing will be discussed and illustrated with case studies. In addition to more traditional formulation topics, examples will include ensuring adequate analytics, transferring fill/finish processes, and ensuring dosing strategies are properly selected and supported through compatibility studies.