*Major boost to patients with blood/immune disorders or severe blood loss
*India can save foreign exchange equivalent to INR 250 Crores through local manufacturing of plasma products.
*Investment of Rs. 100-120 crores to be spread out over the next two years
*GE Healthcare to provide its leading purification technologies, processes and support
Ahmedabad / Bengaluru, January 22, 2009: CELESTIAL BIOLOGICALS LIMITED (CBL), an associated company of Intas Biopharmaceuticals Limited, and GE HEALTHCARE, the US$17 billion healthcare business of General Electric Company (NYSE: GE), announced today 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 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.
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. 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 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. The plasma fractionation facility will also help optimize 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 optimization.
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 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.
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 & 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. 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."
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 Pharmacopeia.
"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. "This is in line with our vision of 'Early Health' for India and we will continuously endeavour to bring in affordable solutions to fill in the technology gap in the region."
Celestial Biologicals is investing Rs. 100-120 crores to develop the Plasma Fractionation unit over the next two years. 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.
The company 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. It has obtained necessary regulatory permission and approval from the government. Company has acquired land in the Pharmaceutical belt around 22 kms. from Ahmedabad for the proposed Plasma Fractionation plant.
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.
GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.
Blood is a living tissue composed of cellular elements and a watery fluid called plasma. Blood supply has a special position in healthcare. Blood is rich source of components that are essential to life. The blood cells and many essential proteins in our blood are used as a medicine for the treatment of a greater number of life-threatening diseases and during high-risk, complex surgery. The road from blood to medicines begins with the generosity of a single donor. Blood cannot be manufactured and there is a serious mismatch between demand and availability of blood in India -- against 8.5 million units/year requirement, only 4.4 million units/year is available (National AIDS Control Organization). It calls for more voluntary collection as well as optimized usage.
The cellular parts comprising of red cells, white cells and platelets makes up nearly 45% of the volume of blood. The Plasma, which makes up the remaining 55% is the source of over 700 proteins of considerable therapeutic value such as albumin, clotting factors, immunoglobulins, fibrinogen and others. The process used to extract and purify these proteins is known as plasma fractionation.
Blood plasma contains thirteen blood-clotting factors. If any one of them is defective, then blood will not clot. For example, clotting disorder due to a missing factor V111 is referred as Haemophilia. Two of these blood-clotting factors are Prothombin and Fibrinogen, which are soluble proteins dissolved in the blood plasma. If a tissue is damaged, it releases a chemical called Thromboplastin. This converts Prothrombin to Thrombin. Thrombin acts on Fibrinogen, converting it to the protein Fibrin. Fibrin is insoluble and forms fibres across the wound. Blood cells and platelets get caught up in the fibres, forming a clot.
Processing blood into various types of medicine is a delicate and sophisticated process, taking into account the variable biological characteristics of blood. In addition, the transmission of infectious diseases must be prevented, necessitating optimal safety procedures during the preparation of blood products.
There are about 2500 approved blood banks in India. (Central Drugs Standard Control Organization, DGHS, Govt. of India.). In India, the bulk demand for the plasma components is met through imports. Plasma and Plasma derivatives are not accessible to the economically poor patients due to high costs. Hemophiliacs need to take Anti Hemophilic factor (AHF) at periodic intervals, lifelong depending on the severity of the condition. Thus the bulk portion of existing demand is met through import of plasma products on estimated foreign exchange amounting to Rs.250 crore annually. The direct benefit of local preparation of Plasma derivatives to needy patients at affordable prices will reduce our dependence to imports of Factor VIII and Factor IX and save foreign exchange.
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