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Inline ultrafiltration.

Christopher A Teske1, Benedicte Lebreton, Robert van Reis

  • 1Late Stage Purification Process R&D, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA. cteske@gene.com

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Summary
This summary is machine-generated.

Inline ultrafiltration (UF) increases recoverable biopharmaceutical mass in processes with limited pool tank volumes. This cost-effective method uses small UF cassettes, offering an alternative to larger tanks for antibody purification.

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Process Engineering
  • Downstream Processing

Background:

  • Increasing cell culture titers present challenges for downstream processing.
  • Limited pool tank volumes can restrict the recoverable mass of biopharmaceutical products.
  • Existing facilities may have constraints on expanding bulk storage capacity.

Purpose of the Study:

  • To demonstrate the efficacy of inline ultrafiltration (UF) in enhancing product recovery.
  • To evaluate inline UF as a solution for processes with volume limitations.
  • To assess the feasibility of inline UF for antibody purification.

Main Methods:

  • Implementation of inline ultrafiltration using commercially available cassettes.
  • Integration of UF within an antibody purification workflow.
  • Quantification of recoverable product mass before and after inline UF implementation.

Main Results:

  • Inline UF significantly increased the recoverable mass of biopharmaceutical products.
  • The use of small, commercially available UF cassettes proved effective.
  • The method was demonstrated within an antibody purification process.

Conclusions:

  • Inline ultrafiltration is a viable strategy to overcome pool tank volume limitations.
  • This approach offers a cost-effective and less disruptive alternative to installing larger tanks.
  • Inline UF enables more efficient biopharmaceutical production in facilities with existing size constraints.