Initiative

Celestial Biologicals To Set Up Fully-Integrated Chromatography-Based Plasma Fractionation Facility

It is a major boost to patients with blood/ immune disorders or severe blood loss

Celestial Biologicals Limited (CBL), an associated company of Intas Biopharmaceuticals Limited, and GE Healthcare, the US$17 billion healthcare business of General Electric Company, announced a collaboration to set up India's first Good Manufacturing Practice (GMP) compliant plasma fractionation facility in Ahmedabad.

The facility will be first of its kind in India. The collaboration will include appropriate technology, products, processes and project development for establishing the plasma fractionation facility. The model being developed in India is replicable in other developing economies dependent on imported plasma products today. A Memorandum of Understanding (MoU) was signed between Celestial Biologicals and GE Healthcare at the Vibrant Gujarat Global Investors Summit 2009. The facility will be fully functional by early 2010.

The market demand for blood products is dynamic and currently plasma products are imported from other countries. It is estimated that one million litre of plasma is required annually in India to meet current clinical demands. Hence, local manufacture is the key to providing plasma products at affordable prices to Indian patients. Local manufacturing also helps reduce delays due to import procedures, transport facilities and helps save precious foreign exchange for the country.

As per various reports, India collects over seven million units of blood every year, but 60 per cent of the blood plasma collected goes to waste because there is no facility available in India for fractionation. The plasma fractionation facility will also help optimise rational use of blood resources and usher in an era of component therapy. Component therapy is a process of transfusing only essential components of blood instead of whole blood for treatment. The balance of components could then be used for other needy patients, bringing in optimisation.

GE Healthcare was chosen as the preferred partner for the project for its technological expertise and the company's platform solution, "With a comprehensive life sciences facility such as the CBL, a diverse range of solutions and process support are required. GE Healthcare demonstrated an attractive proposition because as a key healthcare and life sciences infrastructure provider, they presented a holistic approach to cater for multiple aspects of CBL projects seamlessly," said Dr Urmish Chudgar, MD, Intas Biopharmaceutical Limited.

"The facility gains national importance as it will help us, as a nation, to be self-reliant in life saving proteins extracted from blood plasma. Apart from uplifting the overall transfusion medicine in India, the fractionation facility will lead to develop new plasma products from Indian plasma and help to become a major hub in the SAARC region," he added.

Under this collaboration, CBL and GE Healthcare will jointly set-up a pilot plasma fractionation facility of approximately 15,000 litres to 40,000 litres capacity for at least four products at CBL's existing GMP-compliant facility. The companies will plan scale-up the plasma fractionation facility to 300,000 litres capacity simultaneously.

Both companies will work together in the area of developing the desired technology for plasma fractionation, thereby enabling the companies to leverage their respective strengths in the areas of biotechnology and transfusion medicine and research. The joint plan of action is to successfully execute the implementation of well-established chromatography technology for processing plasma (recovered and source plasma) and recover high yields of purified products on scales of up to 300,000 litres annually.

Celestial Biologicals is investing Rs 100-120 crore to develop the plasma fractionation unit over the next two years. GE Healthcare will provide technology, processes and support to set-up the plasma fractionation facility.

EH News Bureau