Precision Biotherapeutics mAbs and mRNA therapeutics

Name of the Directorate: Biomanufacturing

Name of the Thematic Area: Precision Biotherapeutics: mRNA therapeutics & monoclonal antibodies


Program Overview

Precision biotherapeutics mark a transformative shift toward highly targeted, personalized healthcare, where treatments are designed around an individual’s genetic makeup, lifestyle, or specific disease characteristics. This approach is particularly impactful for complex conditions such as cancer, autoimmune disorders, and rare genetic diseases. In India, the field is rapidly advancing through breakthroughs in genomics, digital health, biotechnology, and Artificial Intelligence (AI), enabling more effective, safer, and faster therapeutic solutions. While challenges related to cost, manufacturing capacity, and specialized infrastructure remain, growing innovation and supportive policy efforts are accelerating India’s transition toward next-generation precision healthcare.

mRNA therapeutics use messenger RNA to train the body to fight or prevent disease, offering a versatile platform for vaccines and advanced treatments. In India, growing research capacity, expanding indigenous mRNA platforms, and expertise in IT and nanobiotechnology are accelerating progress in this space. Rising health challenges and a strong policy push for biomanufacturing are further enabling innovation. Monoclonal antibodies (mAbs) are highly targeted biological drugs widely used in oncology, autoimmune diseases, and chronic conditions. India’s expanding manufacturing capacity, experience in large-scale bioprocessing, and growing capabilities in antibody discovery are strengthening the sector’s competitiveness. While high development costs, complex production processes, and the need for specialized infrastructure remain as challenges, advances in continuous manufacturing, digital optimization tools, and emerging opportunities in biosimilars are shaping a more accessible, efficient, and innovation-driven antibody ecosystem

Mandate

Intensify engagement in futuristic biotherapeutics technologies and personalized medicine to position the country as a global development and manufacturing hub for indigenous and cost effective personalized healthcare solutions.

Thrust Areas

Some of the key focus areas under mRNA therapeutics are Optimizing mRNA Stability and Expression; Next-generation mRNA expression vectors and platforms; mRNA for Infectious Disease Prevention and Treatment; mRNA for Cancer Immunotherapy; Gene Editing and Gene Therapy via mRNA; Personalized mRNA Therapeutics; Immunology of mRNA Vaccines and Therapies; mRNA Delivery Technologies; Scalability and Manufacturing of mRNA Products; Advancing existing POCs (with available animal data) to pre-clinical formulations and pre-clinical formulations to clinical trial phase I/II.

Under the monoclonal antibodies sub-vertical thrust areas include Monoclonal Antibodies for New Therapeutic Targets; Antibody Engineering and Optimization; Development of mAbs for prevention or treatment of emerging infectious diseases (e.g. viral infections, antimicrobial resistance, pandemics) and treatment of oncologic and autoimmune diseases; Innovative solutions for large scale production of mAbs, focusing on cost reduction, scalability, and increasing yield; Applications of mAbs in diagnostics for disease detection, biomarker identification and rapid testing platforms (e.g., point-of-care diagnostics, antibody-based biosensors); Exploration of advanced format, such as nanobodies, single-domain antibodies, and other antibody derivatives etc.

Salient Achievements

DBT- BIRAC Joint Call for Proposal on ‘mRNA therapeutics’ and “monoclonal antibodies’ for fostering high performance Biomanufacturing under BioE3 Policy” were announced in FY 25-26. 62 proposals were received under the mRNA therapeutics call and 87 under the monoclonal antibodies call. 13 projects under mRNA therapeutics and 16 under monoclonal antibodies were shortlisted for financial support by DBT/ BIRAC under this program. Webinar on 'Biomanufacturing of monoclonal antibodies” was organized on 11 Feb 2025 and 'Biomanufacturing of mRNA therapeutics” on 16 May 2025 which were attended by more than 300 participants from academia & industry.