Mab, was originally approved by the US FDA in 2002 for rheumatoid arthritis. This

MAb has been approved in 2005 for the treatment of psoriatic arthritis, in 2007 for

Crohn’s disease, in 2008 for plaque psoriasis and idiopathic juvenile hidradenitis

suppurativa, in 2016 for uveitis, and in 2017 for fingernail psoriasis. The use of

therapeutic MAb initially dominated in the area of autoimmune diseases and cancers.

However, new therapeutic antibodies are being developed for a variety of clinical

conditions including viral and bacterial infections, obesity, diabetes, celiac disease,

Alzheimer’s disease, skin diseases, osteoporosis, etc.

Development of new technologies such as phage-display libraries, single-B cell

PCR followed by cloning and expression of antibody in mammalian cells, and high-

throughput screening systems leading to selection of appropriate clones and culture

in miniatured bioreactor systems have led to cut down the response time to generate

therapeutic antibody. Therapeutic human antibodies are now one of the viable

options in addition to drugs and vaccines for emerging diseases. For example, during

recent COVID-19 pandemic, bio-neutralizing MAbs against COVID-19 have been

made using the above platforms as possible therapeutics, before vaccine (Yu et al.

2020).

22.7

Concluding Comments

Due to exquisite target specificity, MAbs are being increasingly used as therapeutics

and have become one of the important portfolios of the pharmaceutical/biotech

industries. Development of mouse-human chimeric antibody and humanized anti-

body has reduced the risk of development of human anti-mouse antibody and thus

has made a significant contribution in their clinical applications. In recent times, due

to the substantial reduction in the time required for the development of fully human

therapeutic antibodies using single-cell PCR and cloning, high-throughput screening

systems, and improved method of their production, these are being increasingly used

in various clinical manifestations. Development of antibody-drug/radioisotope con-

jugate for targeted delivery, bispecific antibody capable of recognizing two different

targets, have further broaden the scope of MAbs in clinical use. In addition to

cancers and autoimmune disorders, therapeutic MAbs are being developed for

diverse clinical disorders such as obesity, diabetes, celiac disease, Alzheimer’s

disease, viral infections, etc. which are likely to further increase their market share

in future.

Acknowledgments The financial assistant from the National Institute of Immunology, New Delhi,

India, is gratefully acknowledged.

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