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Celestial Biologicals collaborates with GE Healthcare
to set up India's first fully integrated chromatography-based plasma
fractionation facility
- Major boost to patients with blood/immune disorders
or severe blood loss
- India could save foreign exchange equivalent of US$
15 million through local manufacturing of plasma products
- Investment of US$ 20 million to US$ 24 million to be
spread over next two years
- GE Healthcare to provide its leading purification
technologies, processes and support
Ahmedabad/Bangalore, 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 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.
-ENDS-
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$17 billion unit of General Electric Company (NYSE: GE).
Worldwide, GE Healthcare employs more than 46,000 people committed to serving
healthcare professionals and their patients in more than 100 countries. For more
information about GE Healthcare, visit our website at
www.gehealthcare.com
.
For Further Information, Please Contact:
GE Healthcare
Conor McKechnie
+44 1494 498 276
conor.mckechnie@ge.com
College Hill
Lorna Cuddon, Rebecca Walker
+44 (0)20 7457 2020
ge-bioprocess@collegehill.com
India Blood Plasma Facts:
There is a serious mismatch between demand and availability of blood in India –
against an 8.5 million units/year requirement, only 4.4 million units/year are
available (National AIDS Control Organization). It calls for more voluntary
collection as well as optimized usage.
There are about 2500 approved blood banks in India. (Central Drugs Standard
Control Organization, DGHS, Govt. of India.). In India, the bulk demand for the
plasma components is met through imports. Plasma and Plasma derivatives are not
accessible to the economically poor patients due to high costs. Hemophiliacs
need to take Anti Hemophilic factor (AHF) at periodic intervals, lifelong,
depending on the severity of the condition. Thus the bulk portion of existing
demand is met through import of plasma products on estimated foreign exchange
amounting to US$ 15 million 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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