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Abstract
It has been more than three decades since the first monoclonal antibody was approved by the United States Food and Drug Administration (US FDA) in 1986, and during this time, antibody engineering has dramatically evolved. Current antibody drugs have increasingly fewer adverse effects due to their high specificity. As a result, therapeutic antibodies have become the predominant class of new drugs developed in recent years. Over the past five years, antibodies have become the best-selling drugs in the pharmaceutical market, and in 2018, eight of the top ten bestselling drugs worldwide were biologics. The global therapeutic monoclonal antibody market was valued at approximately US$115.2 billion in 2018 and is expected to generate revenue of $150 billion by the end of 2019 and $300 billion by 2025. Thus, the market for therapeutic antibody drugs has experienced explosive growth as new drugs have been approved for treating various human diseases, including many cancers, autoimmune, metabolic and infectious diseases. As of December 2019, 79 therapeutic mAbs have been approved by the US FDA, but there is still significant growth potential. This review summarizes the latest market trends and outlines the preeminent antibody engineering technologies used in the development of therapeutic antibody drugs, such as humanization of monoclonal antibodies, phage display, the human antibody mouse, single B cell antibody technology, and affinity maturation. Finally, future applications and perspectives are also discussed.
Highlights
Monoclonal antibodies are produced by B cells and target antigens
This review summarizes the latest market trends and outlines the preeminent antibody engineering technologies used in the development of therapeutic antibody drugs, such as humanization of monoclonal antibodies, phage display, the human antibody mouse, single B cell antibody technology, and affinity maturation
At least 570 therapeutic Monoclonal antibody (mAb) have been studied in clinical trials by commercial companies [2], and 79 therapeutic mAbs have been approved by the United States Food and Drug Administration (US FDA) and are currently on the market [3], including 30 mAbs for the treatment of cancer (Table 1)
Summary
Monoclonal antibodies (mAbs) are produced by B cells and target antigens. The antigens on pathogens usually induce a strong immune response in patients, making it common for infected individuals to naturally produce high-affinity antibodies [128] To obtain these antibodies, mRNA from the PBMCs of pathogeninfected people can be quickly collected and used as a gene repertoire for a phage-displayed library [129]. The antibody gene repertoires of the ICOB phage antibody library were isolated from the PBMCs of 50 healthy human donors, producing a library size of 60 billion individual scFv clones This collection has been successfully used to select antibodies that bind a wide spectrum of target antigens, including pure recombinant proteins, glycans, cancer cells and virus particles [99, 103, 104]. Secukinumab (Cosentyx, Novartis, human IgG1), binds to proinflammatory cytokine IL-17α to reduce inflammation in
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