Discovery & Development Business Practice, Drug Delivery, Formulation, Quality & Compliance, Small Molecules, Bioprocessing - Upstream & Downstream, Technology and Equipment, Analytical Science, Trends & Forecasts

Relative viscosity screening of monoclonal antibody formulations at low concentration and viscosity

Viscosizer TD provides automated relative viscosity measurements with high reproducibility at low viscosity, to help identify molecules with abnormally high viscosity-concentration profiles at low sample concentrations as early as possible in the development pipeline

05/31/2016

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. Against this constraint, the ability to assess biophysical parameters as key quality attributes as early as possible in candidate validation/early formulation development stages can reduce costs and save time, and minimize risk from prompt identification of potential problem candidates.

High viscosity issues are problematic both during bioprocessing and patient administration. The ability to screen early stage candidates and formulations for abnormal viscosity changes, using measurements at low concentrations and very low sample volumes, can help identify monoclonal antibodies (mAbs) with potential developability issues. Degradation of mAbs most commonly occurs through self-association1, and aggregation can cause changes to the viscosity of formulations2.

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S. Goswami, W. Wang, T. Arakawa, S. Ohtake, Antibodies, 2, 452–500 (2013)
F. He , V.I. Razinkov , C.R. Middaugh, and G.W. Becker, High-Throughput Biophysical Approaches to Therapeutic Protein Development (Chap 2) in L.O. Narhi (ed.) Biophysics for Therapeutic Protein Development, Biophysics for the Life Sciences 4, Springer, New York (2013)
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