US Firms Key in Indian Drug Development

Goodwin Biotechnology Inc. ( Florida, US), a fully-owned subsidiary of Goa-based Wallace Pharmaceuticals is planning to offer contract manufacturing services to Indian biopharmaceutical companies. The company sees India as a “tremendous resource for us, both on the 'Buy' side as well as the 'Sell' side.”

Goodwin has a fourteen year history as a CMO. GBI's predecessor (Goodwin Institute of Cancer Research) manufactured biologics since the mid-1960s. GBI worked with small to mid-sized biotech companies, research organizations like Memorial Sloan Kettering and MD Anderson, the US Government and the National Institutes of Health (NIH), and large pharma companies including Centocor (J&J), GSK, Roche, and Menarini.

The company is extending its GMP mammalian cell culture capabilities by deploying a 500l stirred tank train (including multiple smaller tanks) with variable working volume capacities in the US to be completed by the third quarter of 2006. Similar process development capabilities are planned for India.

Meanwhile, Indian firms are interested in working with a US-based company for help with US FDA regulatory approvals and GMP standards. There are hurdles for Indian companies bringing their products to market in the US due to the changing and complex nature of GMP process development, upstream manufacturing and downstream purification processes, and establishing proof of principle, especially prior to phase III development stages. These processes require intricate knowledge of what the US FDA expects, and how to deal with the FDA. Many Indian drug companies are partnering with US based business development firms that also have a presence in India, like Avani International, to surmount these obstacles.

Source: Pharmabiz, February 7, 2006.