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Impact of Ethanol on Continuous Inline Diafiltration of Liposomal Drug Products
  • Rob Worsham,
  • Vaughan Thomas,
  • Suzanne Farid
Rob Worsham

Corresponding Author:[email protected]

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Vaughan Thomas
University College London
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Suzanne Farid
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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 through tangential flow filtration (TFF). Ethanol 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, ethanol was found to decrease permeability in an inverse manner to ethanol concentration. Further assessment found that dilution of the ethanol 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.
02 May 2023Submitted to Biotechnology Journal
03 May 2023Submission Checks Completed
03 May 2023Assigned to Editor
03 May 2023Reviewer(s) Assigned
25 May 2023Review(s) Completed, Editorial Evaluation Pending
26 May 2023Editorial Decision: Revise Minor
27 Jun 20231st Revision Received
05 Jul 2023Submission Checks Completed
05 Jul 2023Assigned to Editor
05 Jul 2023Reviewer(s) Assigned
06 Jul 2023Review(s) Completed, Editorial Evaluation Pending
07 Jul 2023Editorial Decision: Revise Minor
14 Jul 20232nd Revision Received
17 Jul 2023Submission Checks Completed
17 Jul 2023Assigned to Editor
20 Jul 2023Reviewer(s) Assigned
20 Jul 2023Review(s) Completed, Editorial Evaluation Pending
27 Jul 2023Editorial Decision: Accept