Relative Viscosity Screening of Monoclonal Antibody (mAb) Formulations at Low Concentration and Low Viscosity for Early Stage Developability using Malvern Instrument’s Viscosizer TD

The use of therapeutic antibodies is one of the fastest growing sectors for novel biopharmaceuticals, and the industry is under increasing pressure to deliver new therapies in a timely and safe manner. Biopharmaceutical development processes are lengthy and complex with very specific analytical challenges, and particularly severely limited sample availability at the start of the pipeline. Malvern Viscosizer TD is an automated biophysical characterization tool utilizing Taylor Dispersion Analysis and providing ultra-low volume, solution based molecular size and stability measurement capabilities, combined with microcapillary Poiseuille flow for relative viscosity assessment. This application note details measurements of monoclonal antibodies in various formulation buffers.