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Challenges and solutions for the downstream purification of therapeutic proteins

2023/11/17 by Shuo Tang, Jiaoli Tao, Ying Li · 1 voice · 1 citation
Biochemistry, Genetics and Molecular Biology · Medicine · #Protein purification and stability #Monoclonal and Polyclonal Antibodies Research #Viral Infectious Diseases and Gene Expression in Insects

paper · pdf · doi:10.1093/abt/tbad028

openalex publication_date 2023/11/17 · openalex created_date 2025/10/10 · openalex updated_date 2026/07/20

Abstract

The innovation in recombinant protein technology has brought forth a host of challenges related to the purification of these therapeutic proteins. This article delves into the intricate landscape of developing purification processes for artificially designed therapeutic proteins. The key hurdles include controlling protein reduction, protein capture, ensuring stability, eliminating aggregates, removing host cell proteins and optimizing protein recovery. In this review, we outline the purification strategies in order to obtain products of high purity, highlighting the corresponding solutions to circumvent the unique challenges presented by recombinant therapeutic proteins, and exemplify the practical applications by case studies. Finally, a perspective towards future purification process development is provided.

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