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The Challenges and Breakthroughs in the Development of Diagnostic Monoclonal Antibodies
  • +17
  • Jing Wang,
  • Qitao Song,
  • Tao Yang,
  • Yuanli Li,
  • Lihua Zhang,
  • Jiayan Li,
  • Xiaoxia Xu,
  • Yu Heng,
  • Yanyin Lin,
  • Lulai Xu,
  • Shun Zhang,
  • Jiahui Zhou,
  • Yunbo Liu,
  • Lingyuan Kong,
  • Dingbin Tang,
  • Chengdong Ji,
  • Bing Tan,
  • Weijing Yi,
  • Zhanhui Wang,
  • Pu Liao
Jing Wang
Peking University

Corresponding Author:jingwang89@pku.edu.cn

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Qitao Song
Zybio Inc, Chongqing,
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Tao Yang
Chongqing satellite network system Co., Lit
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Yuanli Li
Zybio Inc
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Lihua Zhang
Zybio Inc
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Jiayan Li
Chongqing High-tech Medical Device Research Institute
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Xiaoxia Xu
Chongqing Essence Biological Engineering
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Yu Heng
Chongqing Essence Biological Engineering
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Yanyin Lin
Chongqing Essence Biological Engineering
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Lulai Xu
Zybio Inc
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Shun Zhang
Zybio Inc
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Jiahui Zhou
Zybio Inc
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Yunbo Liu
Zybio Inc
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Lingyuan Kong
Zybio Inc
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Dingbin Tang
Zybio Inc
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Chengdong Ji
Zybio Inc
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Bing Tan
Zybio Inc
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Weijing Yi
Zybio Inc
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Zhanhui Wang
China Agricultural University
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Pu Liao
Chongqing General Hospital
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Abstract

Over the past century, the field of antibody discovery has undergone significant evolution, excluding the current exploration stage of AI-based antibody generation and the often overlooked non-animal sourced antibody discovery, which typically requires mature in vitro affinity and the selection of high-quality antigen formulations. This journey has traversed various stages, from methods involving serum-based antibody acquisition, the isolation of B cells capable of perpetual antibody production through hybridoma technology, to the in-depth exploration of genetic material using the phage display system, and the current stage involving diverse single B cell screening techniques. Additionally, the emergence of machine learning has brought impressive scientific and technological breakthroughs across research domains, proving to be a powerful application in the field of antibody discovery. However, each technique comes with its limitations, such as variability and control challenges in serum-based acquisition, lengthy and difficult hybridoma-derived antibody development, potential limitations in sequence and epitope diversity due to immunization biases in phage display techniques, and costly single B cell screening. Protein mass spectrometry sequencing, with shorter acquisition time and lower costs, is seen as a shortcut by diagnostic companies, impacting traditional antibody development. In diagnostic antibody development, methodological differences in downstream assays and the impact of constant regions outside the Fv core are often neglected. This paper deeply analyzes challenges, proposing innovative strategies for the next generation of diagnostic antibody development. Aimed at moving closer to the gold standard of antibody discovery, these strategies enhance the competitiveness of diagnostic reagent products.
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04 Jun 2024Editorial Decision: Accept