BharatNotes What is Monoclonal Antibodies?
Monoclonal antibodies (mAbs) are identical antibody molecules manufactured from a single clone of immune cells, each engineered to recognise and bind to one specific target site (epitope) on a molecule such as a virus protein or a cancer-cell marker. Because every molecule in the batch is the same, mAbs are highly specific, reproducible and can be produced in unlimited quantities — qualities that distinguish them from the mixed (polyclonal) antibodies the body makes naturally.
The foundational technique, hybridoma technology, was developed by Georges Köhler and César Milstein in 1975 (published in Nature, 1975). Antibody-producing B cells from an immunised mouse are fused with immortal myeloma cells to form a "hybridoma" that grows indefinitely while secreting a single antibody. The discovery was recognised with a share of the 1984 Nobel Prize in Physiology or Medicine.
Types and Naming
As mouse-derived (murine) antibodies triggered immune rejection in patients, scientists progressively "humanised" them. The traditional naming scheme encoded the source in the suffix before -mab:
| Type | Composition | Traditional suffix | Example |
|---|---|---|---|
| Murine (mouse) | Fully mouse | -omab | Muromonab |
| Chimeric | Human constant + mouse variable | -ximab | Rituximab |
| Humanised | Mostly human, small mouse parts | -zumab | Trastuzumab |
| Fully human | Entirely human | -umab | Adalimumab |
The WHO has since revised the naming convention, retiring the universal -mab stem (from 2021) in favour of new endings such as -tug, -bart, -mig and -ment for newly named antibodies.
Applications and Significance
Monoclonal antibodies work by blocking a target molecule, flagging diseased cells for destruction by the immune system, or modulating signalling pathways. Major uses include:
- Cancer — e.g. trastuzumab (Herceptin) for HER2-positive breast and stomach cancer; immune-checkpoint and tumour-targeting antibodies.
- Infectious disease — anti-SARS-CoV-2 spike-protein antibodies were used against COVID-19; in March 2024 the US FDA granted emergency use authorisation to pemivibart as pre-exposure prophylaxis for severely immunocompromised individuals.
- Autoimmune disease — adalimumab and similar agents for rheumatoid arthritis and inflammatory bowel disease.
- Diagnostics — the workhorse of pregnancy tests, rapid antigen tests and ELISA-based detection.
mAbs are also being investigated as a tool against antimicrobial resistance (research reported September 2024).
India and Current Status
India has emerged as a strong manufacturer of biosimilar monoclonal antibodies — lower-cost versions of off-patent originator biologics. Complex biosimilars including trastuzumab, rituximab and adalimumab are now produced domestically, with approvals accelerating between 2020 and 2024. Biocon's Bengaluru biosimilars facility retained EMA GMP certification following routine inspections in 2024, and the Drugs Controller General of India (DCGI) has cleared multiple mAb biosimilars (for example, a cetuximab biosimilar launched in May 2023). This strengthens India's role as a global biopharma hub and supports affordable access to advanced therapeutics.
UPSC Angle
Focus on the definition, hybridoma technology and Köhler–Milstein (1975), the mouse-to-human progression of antibody types, and concrete applications in cancer, COVID-19 and diagnostics. Connect mAbs to India's biosimilar and biotechnology capability for GS3 answers on indigenisation and affordable healthcare.
