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Challenges and solutions for upstream processing of complex biologics.

Shuya Xu1, Yunlong Wang1, Yawen Yu1

  • 1Department of Antibody Process Development, GenScript ProBio Biotechnology Co., Ltd, Nanjing 21100, China.

Antibody Therapeutics
|April 14, 2026
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Summary
This summary is machine-generated.

This review explores upstream bioprocessing strategies to improve complex biologics production, focusing on enhancing expression, quality, and mitigating challenges like mispairing and aggregation for better therapeutic outcomes.

Keywords:
cell culturebispecific antibodyfusion proteinquality improvementtiter enhancementupstream processing

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Area of Science:

  • Biotechnology
  • Biopharmaceutical Manufacturing
  • Protein Engineering

Background:

  • Complex biologics, including bispecific antibodies and fusion proteins, present unique manufacturing challenges compared to conventional monoclonal antibodies.
  • These challenges include lower expression yields, increased rates of incorrect protein pairing, and heightened sensitivity to cell culture conditions, impacting overall product quality and quantity.

Purpose of the Study:

  • To systematically review and analyze upstream bioprocessing strategies for complex biologics.
  • To identify and discuss methods for mitigating common production challenges and optimizing product quality attributes.

Main Methods:

  • The review leverages process development case studies to evaluate various upstream strategies.
  • Focus areas include titer enhancement, regulation of lactate metabolism, control of acidic charge variants, reduction of protein aggregates and fragments, and optimization of glycosylation.

Main Results:

  • Identified key upstream strategies that effectively address challenges in complex biologics production.
  • Demonstrated improvements in titer, product quality attributes (e.g., charge variants, aggregates), and glycosylation profiles through optimized bioprocessing.

Conclusions:

  • Optimized upstream bioprocessing is critical for overcoming the inherent challenges of complex biologics manufacturing.
  • Future development should focus on integrated strategies for sustained improvement in titer and quality for these advanced therapeutics.