Technological Advances in Antibody-Based Therapeutics Lead New Trends in Disease Treatment｜Institute of Cellular and Organismic Biology, Academia Sinica

Antibody therapeutics have shown remarkable momentum in recent years across oncology and immune-related diseases, establishing themselves as a cornerstone of modern biomedical research and clinical innovation. Sustaining and expanding their clinical impact requires continued, coordinated progress in technology platforms, manufacturing, and delivery strategies.

In recognition of these advancements, the Journal of Biomedical Science commissioned an invited review led by Distinguished Research Fellow Dr. Han-Chung Wu and his team at the Institute of Cellular and Organismic Biology (ICOB) and the Biomedical Translation Research Center (BioTReC), Academia Sinica. The article provides a comprehensive overview of monoclonal antibodies (mAbs) and next-generation antibody-based modalities, spanning technology platforms, engineering optimization, clinical applications, and industry trends. It offers an insightful perspective on recent breakthroughs and future directions, serving as a key reference for the field.

The review highlights five major themes: (1) Technological lineage and methodologies: From hybridoma technology, chimeric/humanized and fully human antibody engineering, and phage display to transgenic animal platforms and single-B-cell discovery, illustrating how these advances enhance specificity, safety, and manufacturability. (2) Market and clinical landscape: As of 2025, the U.S. FDA has approved 144 monoclonal antibody drugs, with over 1,000 candidates in clinical development worldwide. Global antibody therapeutics sales reached USD 267 billion in 2024, underscoring their central role in oncology, immunology, autoimmune, and infectious diseases. (3) Next-generation and new modalities of antibody drugs: Discussion of the design principles and therapeutic potential of antibody-drug conjugates (ADCs), bispecific antibodies (bsAbs), and chimeric antigen receptor T-cell (CAR-T) therapies. (4) Innovation in delivery and manufacturing: Evaluation of mRNA-lipid nanoparticle (mRNA-LNP) systems for in vivo expression of antibodies or bispecific molecules, and integration of artificial intelligence (AI), machine learning (ML), and next-generation sequencing (NGS) to accelerate antibody discovery, affinity maturation, and immunogenicity optimization. (5) From targets to IP and quality: Analysis of intellectual property trends and key therapeutic targets, and examination of how Fc and glycan engineering critically influence clinical performance.

With long-standing expertise in antibody engineering and translational research, Dr. Wu’s team provides a valuable framework to guide innovation in precision medicine, immunotherapy, and infectious-disease control. This publication not only contributes to global understanding of therapeutic antibody development but also helps accelerate the advancement of next-generation antibody drugs from bench to bedside. Co-authors include Dr. Ruei-Min Lu, Hsiao-Ling Chiang, Pei-Yi Yuan, Hsiu-Hua Wang, Chi-Yung Chen, Sushree Shankar Panda, Kang-Hao Liang, Hung-Pin Peng, Shih-Han Ko, Hung-Ju Hsu, Monika Kumari, Yi-Jen Su, Yi-Ting Tse, and Nai-Lin Chou.