The Mumbai-based Reliance Life Sciences is making its foray into the business of recombinant drugs and monoclonal antibodies. The company is setting up cGMP specific facility for the manufacture of high-end recombinant proteins and monoclonal antibodies at IPCL's Rabale complex in Navi Mumbai.

According to informed sources in the company, its actual plan is to construct the facility as per the US FDA requirements to undertake contract manufacturing business also for the international clients.

For this, the company would float a Contract Research and Manufacturing Services (CRAMS) unit aiming at clients interested in outsourcing biopharmaceutical products. The newly proposed facility covers an area of about 30,000 sq feet at the Rabale complex. The company is expected to invest about Rs 35 crore in this expansion plan.

The Rabale complex is in the possession of Reliance Industries, since it acquired IPCL from the Union government in 2002.

"In the beginning, Reliance Life Sciences will manufacture key recombinant products including interferon, streptokinase, erythropoietin, and G-CSF. In the long run the company has plans to introduce 30 high-end biotech drugs. Most of these drugs will be the ones becoming generic over the next 5-6 years," said sources.

Reliance is expecting to achieve critical scale efficiency soon after the commissioning of the facility. "Reliance Life will soon apply for a US FDA certification for the recombinant drugs unit. The company's aim is to target major markets like US and Western Europe, which are yet to be trapped by Indian biopharmaceutical companies," they added.

Industry analysts are excited over the foray of Reliance in the recombinant technology area. "Reliance obviously is looking to enter advanced markets with its recombinant products. Also, the domestic product is expected to grow for high end biotech drugs like streptokinase and interferon," said a senior biotech consultant.

Reliance Life Sciences is already undertaking research in the cell biology area, where dedicated groups are working on assisted reproduction, embryonic stem cells, hematopoietic stem cells, skin cells, tissue engineering, genetics and molecular diagnostics. Reliance Life Science's Cell Biology Research Center in Mumbai is the first of its kind in Asia.

The company's plant biotechnology initiative is focused on medicinal and aromatic plants. Reliance plans to use recombinant DNA technology in the context of medicinal and aromatic plants.