NMITLI Programme of CSIR to Conduct hmAbs Trial to Neutralize COVID-19

The New Millennium Indian Technology Leadership Initiative (NMITLI), launched by the Council of Scientific and Industrial Research (CSIR), spearheaded an important research initiative to develop and test human monoclonal antibodies (hmAbs) capable of neutralising the SARS-CoV-2 virus, responsible for the COVID-19 pandemic. This programme marked a milestone in India’s scientific and technological response to the global health crisis, reflecting the country’s progress in advanced biomedical innovation and its commitment to self-reliance in healthcare technology.

Background and Objective

When the COVID-19 pandemic emerged in 2019 and rapidly spread across the world, there was an urgent need for both preventive and therapeutic solutions. Vaccines offered long-term immunity, but monoclonal antibodies were recognised as an immediate therapeutic option, especially for high-risk and severely affected patients.
In this context, CSIR, India’s premier public research organisation, activated its NMITLI platform to coordinate a national research effort in antibody development. The goal was to create an indigenous therapeutic antibody product capable of neutralising the SARS-CoV-2 virus effectively, offering a domestic alternative to imported biologics.
The project aligned with the national vision of “Atmanirbhar Bharat” (Self-Reliant India) and aimed to enhance India’s preparedness for future infectious disease outbreaks.

About the NMITLI Programme

The New Millennium Indian Technology Leadership Initiative (NMITLI) was launched in 2000 as the largest public–private partnership programme of the CSIR. It was designed to position India as a global technology leader by supporting high-risk, innovation-driven projects. NMITLI encourages collaboration between government research institutions, academia, and industry to develop world-class technologies and products.
During the COVID-19 crisis, NMITLI functioned as a catalyst to mobilise expertise from diverse scientific fields—biotechnology, genomics, molecular biology, and immunology—to rapidly develop therapeutic interventions.

Scientific Approach to hmAbs Development

The human monoclonal antibodies (hmAbs) being developed under this initiative are laboratory-produced molecules designed to mimic the body’s natural immune response. These antibodies are engineered to bind specifically to the spike (S) protein of the SARS-CoV-2 virus, blocking its interaction with the ACE2 receptor on human cells, and thereby preventing viral entry and replication.
Key stages of development included:

• Isolation of B Cells: Blood samples were collected from COVID-19 recovered individuals whose immune systems had produced strong neutralising antibodies.
• Cloning of Antibody Genes: The genetic material from selected B cells was cloned to produce recombinant antibodies.
• Screening for Potent Neutralisers: High-affinity antibodies with strong binding potential to the viral spike protein were identified through advanced screening technologies.
• Pre-clinical Evaluation: The shortlisted antibodies underwent laboratory and animal model testing to assess safety, immunogenicity, and viral neutralisation capability.

The antibodies demonstrating high efficacy were subsequently prepared for human clinical trials.

Collaborative Institutions and Roles

The hmAbs project was executed as a multi-institutional collaboration among several CSIR laboratories and biotechnology firms. Major participating organisations included:

• CSIR-National Centre for Cell Science (NCCS), Pune: Led the development of hybridoma and recombinant antibody technology.
• CSIR-Centre for Cellular and Molecular Biology (CCMB), Hyderabad: Provided genomic sequencing and molecular characterisation support.
• CSIR-Institute of Genomics and Integrative Biology (IGIB), New Delhi: Conducted bioinformatics and computational modelling for antibody optimisation.
• CSIR-Central Drug Research Institute (CDRI), Lucknow: Coordinated pre-clinical and pharmacological studies.
• Private Sector Partners: Contributed to bioprocess development, large-scale production, and regulatory compliance for clinical trials.

This public–private collaboration reflected NMITLI’s philosophy of integrating scientific excellence with industrial application to accelerate product development.

Clinical Trial and Testing

Following successful pre-clinical trials, the CSIR’s NMITLI programme initiated Phase I and II clinical trials for the hmAbs, after obtaining necessary approvals from regulatory authorities such as the Drugs Controller General of India (DCGI) and the Indian Council of Medical Research (ICMR).
These trials were aimed at evaluating:

• Safety and Tolerability in human subjects.
• Pharmacokinetics and optimal dosage levels.
• Efficacy in Neutralising SARS-CoV-2 in patients with mild to moderate symptoms.

The trials also monitored potential side effects and immune responses. If proven effective, these antibodies could be used as an emergency therapeutic intervention for COVID-19 patients, particularly those at risk of severe disease or with compromised immune systems.

Advantages of hmAbs Therapy

Human monoclonal antibodies offer several benefits over conventional treatments:

• Targeted Action: hmAbs specifically bind to viral structures, providing precision therapy.
• Immediate Immunity: Unlike vaccines that take time to stimulate immunity, antibodies provide instant protection.
• Use in High-Risk Groups: Suitable for elderly or immunocompromised individuals who may not respond strongly to vaccines.
• Adaptability: The technology allows quick modification to counter new viral variants.

Additionally, the indigenous production of hmAbs significantly reduces dependency on foreign pharmaceutical companies and lowers treatment costs.

Significance in India’s COVID-19 Response

The CSIR’s NMITLI initiative represented one of the most advanced indigenous scientific responses to the pandemic. While global companies such as Regeneron, Eli Lilly, and AstraZeneca had developed similar antibody-based therapies, India’s NMITLI programme focused on creating a cost-effective and scalable domestic equivalent.
This effort not only contributed to India’s pandemic containment strategy but also established a strong foundation for future biomedical innovation. It demonstrated India’s capacity to conduct end-to-end therapeutic research—from molecular discovery to clinical application—within a national framework.

Broader Impact and Future Prospects

The success of the hmAbs development under NMITLI extends beyond COVID-19. The expertise gained can be leveraged for research into treatments for other infectious diseases such as dengue, chikungunya, Zika, and influenza, as well as non-communicable diseases requiring antibody-based therapies.
Future directions include:

• Establishing a National Antibody Discovery Platform for emerging pathogens.
• Integrating artificial intelligence for predictive modelling of antibody–antigen interactions.
• Expanding biopharmaceutical manufacturing capacity to meet domestic and export demands.

The initiative thus positions India as an emerging leader in biotherapeutic innovation and contributes significantly to its global health diplomacy.