Novel Surfactant Compatibility with Downstream Protein Bioprocesses.

Autor:	Fares HM; Colloids and Biopharma R&D, Pharma Solutions R&D, International Flavors and Fragrances, Wilmington, DE 19803., Carnovale M; Colloids and Biopharma R&D, Pharma Solutions R&D, International Flavors and Fragrances, Wilmington, DE 19803., Tabouguia MON; Colloids and Biopharma R&D, Pharma Solutions R&D, International Flavors and Fragrances, Wilmington, DE 19803., Jordan S; Colloids and Biopharma R&D, Pharma Solutions R&D, International Flavors and Fragrances, Wilmington, DE 19803., Katz JS; Colloids and Biopharma R&D, Pharma Solutions R&D, International Flavors and Fragrances, Wilmington, DE 19803. Electronic address: Joshua.katz@iff.com.
Jazyk:	angličtina
Zdroj:	Journal of pharmaceutical sciences [J Pharm Sci] 2023 Jul; Vol. 112 (7), pp. 1811-1820. Date of Electronic Publication: 2023 Apr 23.
DOI:	10.1016/j.xphs.2023.04.011
Abstrakt:	Downstream processing of antibodies consists of a series of steps aimed at purifying the product and ensuring it is delivered to formulators structurally and functionally intact. The process can be complex and time-consuming, involving multiple filtrations, chromatography, and buffer exchange steps that can interfere with product integrity. This study explores the possibility and benefits of adding N-myristoyl phenylalanine polyether amine diamide (FM1000) as a process aid. FM1000 is a nonionic surfactant that is highly effective at stabilizing proteins against aggregation and particle formation and has been extensively explored as a novel excipient for antibody formulations. In this work, FM1000 is shown to stabilize proteins against pumping-induced aggregation which can occur while transporting them between process units and within certain processes. It is also shown to prevent antibody fouling of multiple polymeric surfaces. Furthermore, FM1000 can be removed after some steps and during buffer exchange in ultrafiltration/diafiltration, if needed. Additionally, FM1000 was compared to polysorbates in studies focusing on surfactant retention on filters and columns. While the different molecular entities of polysorbates elute at different rates, FM1000 flows through purification units as a single molecule and at a faster rate. Overall, this work defines new areas of application for FM1000 within downstream processing and presents it as a versatile process aid, where its addition and removal are tunable depending on the needs of each product. Competing Interests: Declaration of Interests The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2023 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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