Uchchatar Avishkar Yojana: Continuous processing for production of biotech therapeutics

Making Biotherapeutics Affordable: Researchers work towards transforming biopharma industry

In an effort to meet the growing demand of the biopharma industry, researchers at Delhi IIT are working in close collaboration with global industries to build process platforms that will produce faster, better quality and cheaper biotherapeutics.

The project titled—Continuous processing for production of biotech therapeutics—as part of the Uchhatar Avishkar Yojana (UAY) of the Ministry of Human Resource Development (MHRD) entails shifting from the traditional batch processing to a continuous processing model for drug manufacture. The transition that involves an integration of equipment and process steps for converting the raw materials into biotherapeutics.

The Uchhatar Avishkar Yojana was launched by the MHRD with a view to promoting innovation of a higher order that directly impacts the needs of the Industry/industries and thereby improves the competitive edge of Indian manufacturing. The scheme is aimed to promote innovation in areas that are directly of relevance to the manufacturing and design industry, to spur innovative mindset in the students and faculty and to bring a coordinated action between academia and the industry.

Manufacturing of biotherapeutic products has been identified as a key component of the Make in India campaign. The biopharma industry is at present mostly using the batch manufacturing process to produce drugs in which the raw materials are sent in an interrupted mode through different workstations. Besides being more time consuming, they are less cost effective. In contrast the continuous process integrates the various process steps and equipment to produce the end product at a significantly higher productivity (~10X) and thus improved economics.

“The future of biopharma is based on the continuous model and the benefits of continuous processing have been demonstrated on multiple platforms in other industry. This project aims to establish continuous processing as an approach to reduce the cost of manufacturing of biotech therapeutics. Besides higher productivity and improved process economics the other key drivers for transition from batch to continuous processing are the need for better process control and more consistent product quality,” says the project investigator Anurag Rathore who is a professor in the chemical engineering department of Delhi IIT.

An important facet of the project is the significant fund flow from the two industrial partners, Biocon Research Limited (Bangalore, India) and Pall Corporation (Woburn, MA, USA). They have together contributed nearly Rs 3 crores, amply reflecting on their zeal to commercialize the technology. Biocon has committed to contributing Rs 50 lakh in cash besides committing on providing the required process knowledge, analytical method information and process intermediates. Pall Corporation has agreed to contribute Rs 2.5 crore along with helping create hardware solutions and software required for successful integration of various unit operations.

"Collaborations between Industry and Academia is an essential component of advancements in biotechnology. Biocon is working closely with IIT-Delhi in development of next generation processes for biologics, utilizing state-of-the-art technologies, under the UAY program. The research done in this collaboration is expected to yield new and improved processes with the potential to enable Biocon's mission of providing affordable healthcare, through innovation," says Narendra Chirmule, Sr Vice President & Head, Biocon R&D

The project targets two biotech therapeutics—namely granulocyte colony stimulating factor(GCSF) that is expressed in a microbial host(E.coli) and Rituximab, a monoclonal antibody product that is expressed in mammalian cells. Besides the other objectives, the project also aims to establish a state of the art facility, essentially an end to end lab system for demonstration.

The project has its timetable and deadlines and is expected to take three years to reach a stage of dissemination.

IITD Project Team: Anurag Rathore (PI), Anupam Shukla (Co-PI), Manoj Ramteke (Co-PI), James Gomes (Co-PI), Viswanath Hebbi and Nikhil Kateja (PhD Students)