Celestial Biologicals Limited (CBL) and GE Healthcare have announced a collaboration to set up India's first good manufacturing practice (GMP) compliant Plasma Fractionation facility in Ahmedabad.
The collaboration will include appropriate technology, products, processes and project development for establishing the Plasma Fractionation facility.
The model being developed in India can be replicated in other developing economies dependent on imported plasma products.
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 and B, Von-Willebrnd's disease and so on.
The market demand for blood products is dynamic and currently, plasma products are imported from other countries.
It is estimated that one million litres of plasma is required annually in India to meet current clinical demands.
Therefore, 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 foreign exchange for the country.
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.
'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,' said Dr Urmish Chudgar, managing director, Intas Biopharmaceuticals Limited.
'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 to 40,000 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 organised 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.
Both companies will work together in the area of developing the desired technology for plasma fractionation, enabling them to use 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 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.
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.
Celestial Biologicals is investing USD20m to USD24m to develop the Plasma Fractionation unit over the next two years.
GE Healthcare will provide its purifying technologies, processes and support to set up the Plasma Fractionation facility.
