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Celestial Biologicals and GE Healthcare Collaborates to Set up Plasma Fractionation Facility in India

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Celestial Biologicals Limited (CBL) and GE Healthcare, the US$17 billion healthcare business of General Electric Company, announced have a collaboration to set up India’s first Good Manufacturing Practice (GMP) compliant Plasma Fractionation facility in Ahmedabad.

The facility is said to 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 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.

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, Hemophilia-A & B, Von-Willebrnd”s disease, etc.

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, Managing Director, Intas Biopharmaceuticals Limited.

Dr. Chudgar added, “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”.

Under this collaboration, CBL and GE Healthcare will jointly set up a pilot Plasma Fractionation facility of approximately 15,000 liters to 40,000 liters 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 liters capacity simultaneously.

Celestial Biologicals will also explore the possibility of utilizing 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 utilizing the facility for the purpose of contract fractionation.

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 and recover high yields of purified products on scales of up to 300,000 liters annually. The laboratory facilities have already been set up along with plans to include dedicated collection, testing and storage facilities for Plasma as well as other ancillary utilities.”