Research

The Cure Within

The life saving nature of blood was always known, but it’s therapeutic nature had seldom been explored, until plasma fractionation. Suja Nair surveys the scenario

It's a well known fact that fractionated protein products are a very important class of therapeutics. They are sometimes the only available option in the prevention, management, and treatment of life-threatening conditions caused by trauma, congenital deficiencies, immunologic disorders, or infections. Human plasma is the source of over 700 proteins of considerable therapeutic value such as albumin, clotting factors, immunoglobulins, fibrinogen and others. The process of extracting and purifying these proteins is known as plasma fractionation. Explaining the importance of plasma fractionation, Dr Ranjeet Ajmani, Chief Scientific Officer, Celestial Biologicals, says, "Plasma is a very complex biological fluid, which has hundreds of biological active ingredients, including proteins. These proteins have tremendous therapeutic value. In plasma fractionation, proteins are separated either by Cohn method or chromatography. After separation of proteins, the proteins undergo viral inactivation protocols." Ajmani adds that at the moment, there is a huge gap between demand and supply as the market is not well developed because of availability and affordability of the products, partly due to poor diagnosis. As far as imports of products are concerned, products come from countries like China, Hungary and Germany.

Exploring the past

Unfortunately, in India we do not have a single blood fractionating centre, though some companies have recognised the need and are developing them. India collects over seven million units of blood every year, however, more than 60 per cent of plasma collected goes waste because there is no fractionation facility available. As per the Union Ministry of Health, there is a need for a plant with an annual processing capacity of 1,00,000 litres of plasma to meet entire demand of plasma products. Dr Sanjaykumar Jadhav, Assistant Director, Maharashtra State Blood Transfusion Council (SBTC); Member Governing Board, National Blood Transfusion Council (NBTC), Government Of India; Member, Technical Resource Group, Voluntary Blood Donation Committee, NBTC, Government Of India, informs, "India has 2223 blood banks, but only 223 have component preparation facilities ie. plasma separation. However, there are companies like Reliance, who fractionate plasma. Prathma blood centre of Celestial Bioligicals, Ahmedabad get plasma fractionated from Korea." Reliance has a pilot plant for plasma proteins in central Mumbai complying with cGMP guidelines and operating under license from Indian Food and Drug Administration (FDA). The facility is also WHO-GMP certified. Earlier, the National Plasma Fractionation Centre (NPFC) established in 1988-1989 and located in the premises of the KEM Hospital, was the only plasma fractionation centre in India. It was set up to fulfil a long-felt need for safe plasma products in India and had the capacity to fractionate 10,000 litres of plasma annually. It was established as an autonomous unit governed by a trust—Research Foundation for National Blood Transfusion Services—with funds provided by the Swedish International Development Agency, assisted by Brihanmumbai Municipal Corporation (BMC) and Government of India. However, this plant was closed in 2001 due to financial losses.

The trend-setters

"The new fractionation centre we are setting up will be of national importance as it will help us (as a nation) to become self reliant" - Dr Ranjeet Ajmani Chief Scientific Officer Celestial Biologicals

Celestial Biologicals, a subsidiary of Intas Biopharmaceuticals Limited (IBPL), is planning to set up a fractionation facility near Ahmedabad. The company plans to invest Rs 100 to 120 crore over two years on the facility that will have an installed capacity to fractionate 1,50,000 litres of plasma in the initial phase. Later, it plans to scale up to 5,00,000 litres.

Ajmani reveals, "The new fractionation centre we are setting up will be of national importance as it will help us (as a nation) to become self reliant. It will also lead to implementation of the national blood policy, advocating modern and right scientific practice in clinical science. Apart from uplifting the overall transfusion medicine scene in India, it will lead to developing new plasma products from Indian plasma and also help to become a major hub in the SAARC region."

Apart from Celestial Biologics and Reliance Life Sciences, Piramal Healthcare, a part of the Piramal Group, recently completed a definitive agreement with PlasmaSelect AG, Germany, to acquire PlasmaSelect's polygeline-based blood plasma products marketed under the brand name Haemaccel in over 38 countries.

Sharing his company's future plans KV Subramaniam, President and CEO, Reliance Life Sciences, says, "Reliance is commissioning an European Medicines Agency (EMEA) and US FDA compliant commercial scale facility for plasma fractionation at Dhirubhai Ambani Life Sciences Center, Navi Mumbai."

Component therapy

Component therapy is a much safer method for administration instead of whole blood, and also has the advantage of optimum utilisation of blood. Previously, even if a patient required only platelets he was given blood, which resulted in complications. But with the help of blood fractionation, only the components required by patients are administered. By the way of component therapy, at least four products from the same blood can be administered to four different people.

The Indian Government should also take initiatives to collaborate with various companies in order to set up more fractionation centres in order to make India self reliant and meet demand. Jadhav says, "Upgradation of the KEM plasma plant is in process. Government of India is establishing four centres of excellence in Mumbai, Chennai, Delhi and Calcutta for which Rs 468 crore have already been budgeted. So that there will be no problem in future with regard to demand."

Speaking on the need for government initiatives for improving present conditions Ajmani says, "The history of plasma fractionation across the globe has shown that wherever the government has supported plasma fractionation, it has improved the quality of life of people who use these products. Since it is a very complex project, it requires to be comprehensively and thoroughly understood by the government as well as regulatory authorities."

Subramaniam suggests that the government should encourage all blood banks to separate collected blood into its components so that the surplus plasma generated can be used for fractionation and the country's need for blood products can be met without having to import the same. The government should also encourage plasmapheresis programs to generate more plasma for fractionation. This would have a bearing on the cost of the product, bringing it down significantly and thereby making it available to a larger population.

Looks like this is another sector where the industry and patient population is totally dependent on the government to extend a lifeline of critical support.

suja.nair@expressindia.com