Institute for International Research

IBC's 5th Annual Biophysical Analysis for Bioprocessing provided analytical scientists with a forum to exchange best practices for applying biophysical analytical methods (including DLS, FFF, Static Light Scattering and AUC) alone and together to improve product quality from research through preclinical product development. Delegates gained valuable perspectives on the development, use and analysis of biophysical experiments from others working in the field.

Conference Highlights

• Bristol-Myers Squibb, Genentech and Human Genome Sciences detail structural analyses to determine structure-function relationships, solution dynamics and comparability following process changes
• MedImmune, NIST, United States Pharmacopeia and University of Colorado track progress in developing new methods to characterize and control submicron, subvisible and visible particles
• Amylin, Genzyme, KBI Biopharma, Merck and Takeda demonstrate best practices for using biophysical analysis to add value from the research stage though product development
• Genentech and Human Genome Sciences share case studies of how multiple biophysical studies can be combined to improve the quality and validity of experiments

Keynote Presentations

Determination of Reversible Self-Association at High Protein Concentration and its Impact on Viscosity
Steven J. Shire, Ph.D., Staff Scientist and Group Leader, Late Stage Pharmaceutical and Process Development, Genentech, Inc.

Status of Compendial Assays and Standards Development for Measurement of Subvisible and Visible Particles
D. Scott Aldrich, Principal Consultant, Ultramikro LLC; Member, United States Pharmacopeia Parenteral Products Industrial Expert Committee