What are Monoclonal Antibodies (mAbs)?
Antibodies are proteins generated by the immune system to defend ourselves from diseases. Monoclonal antibodies (mAbs) are engineered antibodies that mimic human antibodies. They are expressed from a single type of immune cell to create identical copies, hence the name monoclonal.
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Are Monoclonal Antibodies (mAbs) Biologics?
Yes. Biologics also known as biopharmaceuticals or biological medical products are derived from natural sources rather than being chemically synthesized, and include vaccines, hormones, gene therapies, insulin, plasma-derived medicines, and antibodies.
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How are Monoclonal Antibodies (mAbs) Produced?
Monoclonal Antibodies (mAbs) are produced in a lab, with support from molecular biology and protein and genetic engineering. There are multiple different methods.
In general, the process involves isolating the cells that make antibodies – often from people who have recovered from an infection – and cloning them to ultimately manufacture them at scale in large bioreactors.
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What is the difference between Monoclonal Antibodies (mAbs) and vaccines?
Vaccines work by inducing the production of antibodies in our bodies. A vaccine is administered to healthy individuals to enable an immune response (including the generation of antibodies). This takes a few weeks, after which we are primed to fight infection if exposed to a given pathogen.
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Administering mAbs directly provides our body with the most powerful antibodies to protect ourselves from or treat an infection, therefore working almost immediately.
Another way of rapidly providing such a line of defence is by transfusing blood plasma (rich in antibodies) obtained from convalescent individuals. However, this method cannot be brought to an industrial scale and is not considered feasible in most low- and middle-income countries (LMICs).
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What are the uses of Monoclonal Antibodies (mAbs)?
Monoclonal antibodies are used for diagnosis, disease treatment and research. They’re used:
As probes to identify materials in laboratories or for use in home-testing kits like those for pregnancy or ovulation.
To type tissue and blood for use in transplants.
For diagnosis.
For disease treatment.
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What types of diseases do monoclonal antibodies treat?
Monoclonal antibodies have been used to treat the following conditions: Cancer; Organ transplant rejection; Inflammatory and autoimmune disorders including allergies; Infections including COVID-19, Ebola and Nipah; Osteoporosis; Eye conditions; Migraines; High cholesterol and Nervous system disorders.
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What are the advantages of using monoclonal antibodies?
One key advantage of using monoclonal antibodies is they’ve been used to make drugs that have been more successful at treating certain diseases, such as some cancers.
Another advantage of using monoclonal antibodies as a treatment is that they’re more precise than other treatments. This improves the effectiveness and can reduce some side effects.
Monoclonal antibody quality is standard for all production batches, which is important for use as therapy, as well as for diagnostics.
It’s now possible to make monoclonal antibodies in large quantities.
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Why are Monoclonal Antibodies (mAbs) so expensive and can prices go down?
Monoclonal antibodies are among the world’s most expensive treatments. The current mAbs market is based on high prices and low volumes. In the US, mAb treatments for cancer can exceed USD $10,000 per month.
Compared to small molecules, Monoclonal Antibodies (mAbs) are expensive to make due to complex biomanufacturing processes and resource-intensive regulatory requirements. In addition, the lack of an established market and limited visibility on demand can keep prices high.
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There are opportunities to decrease development and manufacturing costs through novel, higher-yield technologies and more disruptive innovations that are in the pipeline to further simplify antibody-based therapies and their manufacturing.
Product optimization could also decrease costs, for example by increasing potencies and therefore reducing dose requirements.
Due to weight-based dosing, mAbs for infants and small children can also be produced at lower cost.
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What are the challenges in using monoclonal antibodies?
Infusion reactions are common, and occur during or shortly after monoclonal antibody treatment. These occur when your body has a strong immune response to the monoclonal antibody treatment. Common signs of infusion reaction are rash, fever, rigors/chills, shortness of breath, sweating, changes in blood pressure and increased heart rate.
There’re more serious but less common risks linked to unwanted immune system reactions, such as acute anaphylaxis, cytokine release syndrome (CRS) and serum sickness.
Acute anaphylaxis is a massive allergic reaction that can be life-threatening. Serum sickness happens when your body’s immune system attacks the antiserum, or a blood product containing the proteins that your healthcare team is using to try to help you. CRS is also called cytokine storm and can lead to organ damage.
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PRACTICE QUESTIONS
QUES . With reference to monoclonal antibodies, often mentioned in news, consider the following statements: UPSC PRELIMS 2025
I. They are man-made proteins.
II. They stimulate immunological function due to their ability to bind to specific antigens.
III. They are used in treating viral infections like that of Nipah virus.
Which of the statements given above are correct?
(a) I and II only
(b) II and III only
(c) I and III only
(d) I, II and III
Answer – (d)
