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 liters 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 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 (recovered and source 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.”
GE Healthcare is a 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 endeavor to bring in affordable solutions to fill in the technology gap in the region.”
Celestial Biologicals is investing US$20 million to US$24 million 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 fulfill the increasing demand for plasma products in India. The company will continue to rely on contract fractionation till its own facility starts operating.
About Celestial Biologicals Limited:
The Company is involved in plasma sourcing, contractual fractionation and marketing of plasma-derived products such as human Albumin, Immunoglobulin and Factor VIII. The 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.
About GE Healthcare:
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 US$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.
