Ease of administration and a decrease in administration frequency is a driver for the production of high concentration formulated monoclonal antibody (MAb) drug substances. A challenge in producing high concentration MAb formulations is the exponential increase in viscosity with increased concentration of some MAb pools. This study explores the use of various TFF filters, under different modes of operation, for their suitability in concentrating high viscosity drug products. During each of these operations, process parameters were varied to determine their effects on process performance.

Optimization of tangential flow filtration unit operations for high viscosity protein pools

247th National Meeting (2014)

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