The Challenges and Breakthroughs in the Development of Diagnostic
Monoclonal Antibodies
- 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
Jiayan Li
Chongqing High-tech Medical Device Research Institute
Author ProfileAbstract
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.04 Jun 2024Editorial Decision: Accept