IIT Bombay's Latest Facility to Bridge the Gap between Real-World and Laboratory Activities

The state-of-the-art 10X GMP facility at IIT Bombay will expedite the translation of academic research into innovative medical products, bridging the gap between laboratory discoveries and real-world impact.

The 10X GMP Facility at IIT Bombay is the first-of-its-kind in India and will allow for a seamless transition from concept to commercialization. By fostering collaboration, innovation, and excellence, the facility will redefine medical solutions, drive progress, and accelerate advancements in healthcare and biotechnology. While the 10X GMP facility currently serves the biotech and healthcare domains, it is built for broader applications in the future. Its versatility and wide spectrum of uses position it for promising growth and success across various industries in the future.

At the launch of the 10X GMP facility, Prof. Subhasis Chaudhuri, Director of IIT Bombay, emphasized its transformative potential and said, “The setting up of the 10X GMP Facility will be amongst the first of its kind in India and symbolizes IIT Bombay’s unwavering commitment to bridging the chasm between academic prowess and real-world impact. From cancer theragnostic agents to bioactive wound dressings for diabetic wounds, the facility will accelerate the development of diverse products for healthcare and environmental sustainability."

The 10X GMP facility will enable the manufacturing of materials essential for human clinical trials, including nanomaterials, tissue-engineered grafts, CAR-T constructs, and drug nanoparticles, and expedite the delivery of life-saving solutions to the market. It will develop GMP-grade nanomaterials for pre-clinical testing of theragnostic agents, insulin patches, skin substitutes, wound dressings, and 3D disease models. In his address, Prof. Chaudhuri also acknowledged the generous support of IIT Bombay’s distinguished alumnus, Mr. Raj Nair, whose philanthropic contributions were crucial to the setting up of the facility. “We are deeply grateful to our distinguished alumnus, Mr. Raj Nair, who epitomizes the spirit of philanthropy and collaboration,” he said. “Mr. Nair's contribution will

advance our goal of bringing laboratory-produced products to the market swiftly, enhancing real- world applications for the benefit of the masses with improved speed and effectiveness," he added.

The Chief Guest, Dr. C.S. Pramesh, Director of the Tata Memorial Hospital and the Professor and Head of Thoracic Surgery at the Tata Memorial Centre, Mumbai, delivered an insightful address on the potential of the new facility saying, “The facility bridges the gap for several years in academia. Globally, biomedical human trials happen in academic centres, while in India much of the discovery part happens in the pharmaceutical industry, and I am hopeful that this facility changes this entire process on its head. While we strive for cheaper solutions, we should not overlook the quality of the product. I really like the name 10X, the fact that it is not just ten times cheaper, but ten times better. Indigenous solutions are paramount. We should strive to be solution provider for low- and middle- income countries”.

Mr. Raj Nair, Distinguished Alumnus (B.Tech., 1971, Metallurgical Engineering) and Chairman of Avalon Consulting, Germinait Solutions and AGR Knowledge Solutions, has tirelessly worked over two years to provide highly affordable medical solutions to society that have been instrumental in making the facility a reality. As he took to the stage to share his vision for the Centre, he said, “I believe the greatest gift to the underprivileged is providing highly affordable breakthrough medical solutions since it is well documented that one major illness like cancer, bypass surgery, etc., or a major accident, can send a lower middle class or poor family into abject penury. The 10X GMP facility has been set up to encourage brilliant researchers at IIT Bombay to aim for breakthroughs that are 10 times cheaper, better, or faster than all known treatments. I believe only that can move the needle for society”.

He added, “The availability of a BSL3 GMP facility on the campus also helps reduce the cost of manufacturing products for human trials and shorten the time it takes to get life-saving solutions to the market. I envision a day in the near future when researchers at IIT Bombay will provide millions of people, with a continual flow of solutions to major human problems ranging from Alzheimer’s to cancer, from drug-resistant TB to COVID-19, etc., and all that at a fraction of the

cost of treatment available in other parts of the world”. Apart from the virtual inauguration of the 10X GMP facility, other key events at the occasion included addresses by the Guest of Honour Dr. Raman Gangakhedkar, Former Dr. CG Pandit

National Chair, Indian Council of Medical Research and Head, Division of Epidemiology & Communicable Diseases (ECD), ICMR, New Delhi; and Director-in-Charge, National AIDS Research Institute, Pune, and the Guest Speaker Dr. G. S. Bhuvaneshwar, Adjunct Prof., Department of Engineering Design & Distinguished Alumnus, IIT Madras, Former Head, Biomedical Technology, SCTIMST; presentation of Team GMP by Mr. Ajit M. Jawle, Managing Director Knexir Consultants Pvt. Ltd., another esteemed IIT Bombay alumnus who contributed significantly to the facility's development. Prof. Ravi Gudi’s vote of thanks rounded off the event.

The panel discussion on World Class MedTech Manufacturing through Goods Manufacturing Practice (GMP) and Quality Management Systems (QMS) discussed the need for change in mindset towards research as well as the need for multidisciplinary research & collaboration. They also reiterated the need for a robust framework and SOPs for quality control to overcome quality issues and produce viable products. The panellist discussed the need for industry support to build indigenous solutions that can be used for national good.