Membrane filtration plays an important role in bioprocessing, as nearly every unit operation utilizes a membrane for process protection. Late-stage bioprocesses often require large volume manufacturing to meet supply requirements, and increased volumes can create challenging filtration operations. Large volume operations, especially those with low filter capacity and flux, can disrupt facility fit. These situations require creative solutions or undesirable capital purchases. The body of work to be presented explores many different approaches to allow facility fit for process intermediate filtration and media filtration of a 15k-liter processes, including a focus on process conditions, inclusion of prefilters, and the use of a novel high-area membrane filter. Results show that facility fit can be met using these troubleshooting techniques, and the outcome prevented the need for an expensive and time-consuming capital purchase, as well as a robust understanding of all filtration unit operations.

Challenges in facility fit: Establishing a robust process for filtration of process intermediates

2019 Spring National Meeting

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