Monoclonal antibodies are being formulated to high concentrations to meet target product profile requirements of a single, low volume subcutaneous delivery. Achieving such high concentration targets provide unique challenges for the Tangential Flow Filtration (TFF) operation used in manufacturing: controlling final excipient concentrations, higher viscosity and associated system constraints, and over concentration to maximize recovery.  In this case study we will discuss the technology transfer and scale up of a high concentration, high viscosity TFF operation to an existing manufacturing facility. We will discuss the preparation activities performed to assess the suitability of the existing equipment for this operation. We will also discuss the challenges presented by the equipment design during the scale up of the operation and the steps taken to alleviate system constraints and enable the TFF operation to deliver high concentration drug substance.

Scale up and technology transfer of a high-concentration high-viscosity TFF operation: A case study

247th National Meeting (2014)

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