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An ultra scale-down method to investigate monoclonal antibody processing during tangential flow filtration (TFF) using ultrafiltration membranes

Fernandez-Cerezo, L; Rayat, ACME; Chatel, A; Pollard, JM; Lye, GJ; Hoare, M; (2019) An ultra scale-down method to investigate monoclonal antibody processing during tangential flow filtration (TFF) using ultrafiltration membranes. Biotechnology and Bioengineering , 116 pp. 581-590. 10.1002/bit.26859. Green open access

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Abstract

The availability of material for experimental studies is a key constraint in the development of full-scale bioprocesses. This is especially true for the later stages in a bioprocess sequence such as purification and formulation, where the product is at a relatively high concentration and traditional scale-down models can require significant volumes. Using a combination of critical flow regime analysis, bioprocess modelling and experimentation, ultra scale-down (USD) methods can yield bioprocess information using only millilitre quantities prior to embarking on highly demanding full-scale studies. In this study the performance of a pilot-scale tangential flow filtration (TFF) system based on a membrane flat-sheet cassette using pumped flow was predicted by devising an USD device comprising a stirred cell using a rotating disc. The USD device operates with just 2.1 cm2 of membrane area and for example just 1.7 mL of feed for diafiltration studies. The novel features of the design involve optimisation of the disc location and the membrane configuration to yield an approximately uniform shear rate. This is as characterised using computational fluid dynamics for a defined layer above the membrane surface. A pilot-scale TFF device operating at ~500-fold larger feed volume and membrane area was characterised in terms of the shear rate derived from flow rate-pressure drop relationships for the cassette. Good agreement was achieved between the USD and TFF devices for the flux and resistance values at equivalent average shear rates for a monoclonal antibody diafiltration stage. This article is protected by copyright. All rights reserved.

Type: Article
Title: An ultra scale-down method to investigate monoclonal antibody processing during tangential flow filtration (TFF) using ultrafiltration membranes
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1002/bit.26859
Publisher version: https://doi.org/10.1002/bit.26859
Language: English
Additional information: This work is licensed under a Creative Commons Attribution 4.0 International License. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/
Keywords: CFD, Monoclonal antibody diafiltration, TFF, membrane, ultra scale-down
UCL classification: UCL
UCL > Provost and Vice Provost Offices > UCL BEAMS
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Dept of Biochemical Engineering
URI: https://discovery.ucl.ac.uk/id/eprint/10063967
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