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Impact of ethanol on continuous inline diafiltration of liposomal drug products

Worsham, Robert D; Thomas, Vaughan; Farid, Suzanne S; (2023) Impact of ethanol on continuous inline diafiltration of liposomal drug products. Biotechnology Journal 10.1002/biot.202300194. (In press). Green open access

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Abstract

Liposomal drug products are playing an increasing role in the field of drug delivery. With this increased demand comes the need to increase the capabilities and capacity of manufacturing options. Continuous manufacturing techniques present a significant opportunity to address these needs for liposomal manufacturing processes. Liposomal formulations have unique considerations that impact translation from batch to continuous process designs. This article examines aspects of converting to a continuous design that were previously viewed as inconsequential in a batch process. The batch process involves the removal of ethanol (EtOH) through tangential flow filtration (TFF). EtOH was found to reduce the permeability of the hollow fibers used for TFF. This effect was determined to have minimal impact on the overall batch process design but considerable influence on the design of continuous TFF such as inline diafiltration (ILDF). Using a pilot scale setup, EtOH was found to decrease permeability in an inverse manner to EtOH concentration. Further assessment found that dilution of the EtOH levels prior to diafiltration can significantly reduce the amount of ILDF stages needed and that a continuous design requires less buffer to the commensurate batch design.

Type: Article
Title: Impact of ethanol on continuous inline diafiltration of liposomal drug products
Location: Germany
Open access status: An open access version is available from UCL Discovery
DOI: 10.1002/biot.202300194
Publisher version: https://doi.org/10.1002/biot.202300194
Language: English
Additional information: © 2023 The Authors. Biotechnology Journal published by Wiley-VCH GmbH. This is an open access article under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/).
Keywords: continuous manufacturing, inline diafiltration (ILDF), liposomes, single-use, tangential flow filtration (TFF)
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/10175965
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