Issue 51, 2023

Stabilization challenges and aggregation in protein-based therapeutics in the pharmaceutical industry

Abstract

Protein-based therapeutics have revolutionized the pharmaceutical industry and become vital components in the development of future therapeutics. They offer several advantages over traditional small molecule drugs, including high affinity, potency and specificity, while demonstrating low toxicity and minimal adverse effects. However, the development and manufacturing processes of protein-based therapeutics presents challenges related to protein folding, purification, stability and immunogenicity that should be addressed. These proteins, like other biological molecules, are prone to chemical and physical instabilities. The stability of protein-based drugs throughout the entire manufacturing, storage and delivery process is essential. The occurrence of structural instability resulting from misfolding, unfolding, and modifications, as well as aggregation, poses a significant risk to the efficacy of these drugs, overshadowing their promising attributes. Gaining insight into structural alterations caused by aggregation and their impact on immunogenicity is vital for the advancement and refinement of protein therapeutics. Hence, in this review, we have discussed some features of protein aggregation during production, formulation and storage as well as stabilization strategies in protein engineering and computational methods to prevent aggregation.

Graphical abstract: Stabilization challenges and aggregation in protein-based therapeutics in the pharmaceutical industry

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Article information

Article type
Review Article
Submitted
22 Sep 2023
Accepted
30 Nov 2023
First published
11 Dec 2023
This article is Open Access
Creative Commons BY license

RSC Adv., 2023,13, 35947-35963

Stabilization challenges and aggregation in protein-based therapeutics in the pharmaceutical industry

M. Rahban, F. Ahmad, M. A. Piatyszek, T. Haertlé, L. Saso and A. A. Saboury, RSC Adv., 2023, 13, 35947 DOI: 10.1039/D3RA06476J

This article is licensed under a Creative Commons Attribution 3.0 Unported Licence. You can use material from this article in other publications without requesting further permissions from the RSC, provided that the correct acknowledgement is given.

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