To give impetus to biopharmaceutical research and manufacturing, the Telangana government on Sunday announced that it is developing Biopharma Hub (B-hub), which will be the first of its kind growth phase centre and biopharma scale-up manufacturing facility in India. Industry and Information Technology Minister K.T Rama Rao tweeted that B-Hub will be operational in 15 months and will help consolidate Telangana's leadership position in biopharma. "With built-up area of 100,000 square feet in 2 phases, B-Hub will compliment the extraordinary ecosystem at Genome Valley in Hyderabad (sic)," he said, in a series of tweets.
The facility is being developed by the Telangana State Industrial Infrastructure Corporation Ltd and Telangana Life Sciences, in a unique partnership model with the Centre's Department of Biotechnology, Cytiva, and Cerestra Ventures. "The project is envisioned to be an accelerator for biopharma innovation featuring next gen lab suites, encouraging both startups and midsized companies to interact and collaborate through collective spaces and lead innovation," said Rama Rao.
According to an official note released from the minister's office, annual sales of biopharmaceuticals are now over $200 billion globally, and industry revenue continues to grow at 15% annually. An increasing number and percentage of pharmaceuticals entering the market are biopharmaceuticals, with about 40% of Big Pharma and overall pharmaceutical R&D/pipelines now involving biopharmaceuticals, not drugs (chemical substances).
A biopharma scale-up manufacturing facility with a turnkey laboratory space is a key requirement to facilitate the growth of biosimilars in the life sciences industry. Biopharmaceutical companies are aspiring to advance a molecule from the laboratory to the clinic as quickly as possible without sacrificing product quality, process efficiency, or patient safety. To achieve this goal, companies must navigate the complexities associated with business planning, cell line development, process development, technology, and regulatory and risk assessment, it said.
There is no such full-fledged infrastructure anywhere in the country on date and establishment of an end-to-end biopharma upscale facility including bioreactors and vessels which contain cell culture media to the filtration units and the downstream chromatography processes will provide a platform for the start-ups, mid-sized and even large biopharma companies to carry out their pre-clinical validation in the proposed facility, before making significant capex investment in the product.
"There is a significant demand for such a facility that will reduce the time to market for our companies and single-use set-up ensures adherence to world class regulatory norms," it added.
Hyderabad has emerged as a leader in pharmaceutical and biotechnology and is well positioned to host such a facility. It is a major scientific and R&D hub with presence of globally renowned institutions such as the Indian Institute of Chemical Technology (IICT), the Centre for Cellular and Molecular Biology (CCMB), the Centre for DNA Fingerprinting and Diagnostics (CDFD), among many others and over 800 life sciences companies.
Over the last four decades, Telangana has seen exponential growth in pharmaceuticals accounting for one-third of the country's pharmaceutical production and 30% of all ANDA (Abbreviated New Drug Approval) approvals received by the Indian companies from US FDA. Hyderabad is recognised as the vaccine hub of India and the world, producing about 33% of global vaccines dosages and significantly contributing to elimination of global pain and disease.