Biotechnology Institute THSTI Seeks Partners To Develop Monoclonal Antibody Drug

Last Updated:August 25, 2025, 10:34 IST

The project, valued at Rs 10 crore and expected to be completed within 12 months, also includes carrying out quality and safety studies to meet regulatory standards

Monoclonal antibodies are lab-made proteins designed to act like precision-guided weapons in the body. (Representative Image)

India’s premier biotechnology research institute has invited drug-makers to partner in developing a new monoclonal antibody (mAb) drug—a type of lab-made protein often described as a “smart medicine" because it can precisely target harmful cells in the body.

The project, undertaken by the Biotechnology Research and Innovation Council – Translational Health Science and Technology Institute (BRIC-THSTI), aims to take the experimental therapy from research to GMP manufacturing, paving the way for clinical trials.

According to the Expression of Interest (EOI) document seen by News18, the selected agency will be responsible for creating a master cell bank, establishing a scalable manufacturing process, and supplying the drug for pre-clinical and Phase-I clinical trials.

The project valued at Rs 10 crore also includes carrying out quality and safety studies to meet regulatory standards and is expected to be completed within 12 months.

BRIC-THSTI, Faridabad, is an institute under the Department of Biotechnology, Ministry of Science and Technology. According to EOI, it has developed “a novel human monoclonal antibody (mAb) with the potential to function as a therapeutic drug against pathogenic organisms of interest".

The mAb, the document said, has been developed to the Research Cell Bank (RCB) stage and is now ready for progression into GMP-compliant manufacturing for Investigational New Drug (IND).

In biologics, Research Cell Bank (RCB) is the early stock of cells that produce the monoclonal antibody. It’s created during the discovery stage and serves as the starting source. From this, a Master Cell Bank is later developed, which is fully tested and used for large-scale, regulatory-approved drug manufacturing.

The institute has already developed the antibody up to the research stage and is now seeking industry collaboration to advance it further for Investigational New Drug (IND) filing in India and abroad.

Interested firms have been asked to submit their bids by September 10, 2025.

What are Monoclonal Antibodies?

Monoclonal antibodies are lab-made proteins designed to act like precision-guided weapons in the body. Unlike natural antibodies, which are produced in response to many different threats, monoclonal antibodies originate from a single cell clone and are highly specific to one target, such as a cancer cell or a virus. By binding precisely to that target, they can block its activity, mark it for destruction by the immune system, or even deliver a therapeutic payload directly to it.

These therapies have revolutionised modern medicine. In cancer, drugs like trastuzumab, better known as Herceptin, are used to target breast cancer cells that express the HER2 receptor. In autoimmune diseases such as arthritis, monoclonal antibodies like adalimumab, marketed as Humira, help reduce harmful inflammation. They are also used in infectious diseases, where they can be engineered to neutralise viruses or bacteria, and in chronic inflammatory conditions such as asthma or Crohn’s disease. Their high specificity makes them powerful tools for both treatment and diagnosis, often with fewer side effects compared to conventional therapies.

Himani Chandna

Himani Chandna, Associate Editor at CNN News18, specialises in healthcare and pharmaceuticals. With firsthand insights into India's COVID-19 battle, she brings a seasoned perspective. She is particularly pass...Read More

Himani Chandna, Associate Editor at CNN News18, specialises in healthcare and pharmaceuticals. With firsthand insights into India's COVID-19 battle, she brings a seasoned perspective. She is particularly pass...

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August 25, 2025, 10:34 IST

News india Biotechnology Institute THSTI Seeks Partners To Develop Monoclonal Antibody Drug

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