Celestial Biologicals Limited (CBL), an associated company of Intas Biopharmaceuticals Ltd and GE Healthcare have teamed up to set up India's first Good Manufacturing Practice (GMP) compliant plasma fractionation facility in Ahmedabad. Celestial is investing between Rs 100-120 crore for the next two years.

The collaboration will include appropriate technology, products, processes and project development for establishing the Plasma Fractionation facility. A Memorandum of Understanding was signed between Celestial Biologicals and GE Healthcare at the recently concluded Vibrant Gujarat Global Investors Summit 2009. The facility will be fully functional by early 2010 and is the first-of-its-kind in the country.

GE Healthcare will provide its leading purifying technologies, processes and support to set up the Plasma Fractionation facility. Celestial Biologicals has a contractual arrangement with South Korea based plasma fractionators for fractionation of plasma to fulfil the increasing demand for plasma products in India. The company will continue to rely on contract fractionation till its own facility starts operating.

Human plasma, a liquid component of blood, is the source of many life-saving proteins. A large number of these proteins can be isolated and used in medicine. The process of extracting and purifying these proteins is known as plasma fractionation. Fractionated proteins are used in the prevention, management and treatment of life threatening conditions caused by trauma, congenital deficiencies, immunologic disorders, infections, Haemophilia-A & B, Von-Willebrnd's disease, etc.

The market demand for blood products is dynamic and currently plasma products are imported from other countries. It is estimated that 1 million litres 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. As per various reports, India collects over 7 million units of blood every year, but 60% of the blood plasma collected goes to waste because there is no facility available in India for fractionation.

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," said Dr Urmish Chudgar, managing director, Intas Biopharmaceuticals 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 said.

Under this collaboration, CBL and GE Healthcare will jointly set up a pilot Plasma Fractionation facility of approximately 15000 litres to 40000 litres capacity for at least four products at CBL's existing GMP-compliant facility. The companies will plan scale-up of the Plasma Fractionation facility to 300,000 litres capacity simultaneously. Celestial Biologicals will also explore the possibility of utilising the facility for the purpose of contract fractionation. Celestial Biologicals is the first company to undertake organized collection of plasma, which is key to the plasma fractionation process. It will also explore the possibility of utilising the facility for the purpose of contract fractionation.

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 involved in plasma sourcing, contractual fractionation and marketing of plasma-derived products such as human Albumin, Immunoglobulin and Factor VIII. Company has undertaken a societal need based project and is sourcing plasma from various blood banks of India.

GE Healthcare is the global leader in enabling technologies for biopharma. The state-of-the-art Plasma Fractionation unit with CBL will use Chromatography technology that is now in widespread use across the globe to produce a new range of biologics. These chromatographic processes give final products that meet the highest purity requirements specified by US and EU Pharmacopoeia.

"The robustness of the overall GE Healthcare plasma purification process makes it very well suited to Indian conditions," said Anurag Gupta, managing director, Life Sciences, GE Healthcare.