17 October, Chandigarh
Scientists at CSIR-Institute of Microbial Technology (IMTECH) have developed a technology to produce biotherapeutic proteins like Erythropoietin and Streptokinase.
The indigenous technology will bring down costs of insulin, medicines for Hepatitis B, Cancer, anaemia, heart attack and several other diseases drastically.
Currently, India imports patented Biotherapeutic proteins for production of insulin, Streptokinase (blood clot buster), Hepatitis B vaccine, etc, despite India’s pre-eminence as the largest exporter of generic medicines worldwide.
Erythropoietin is a key component for anti-anaemic medicines, while Streptokinase is for treatment of blood clots that blocked arteries or lung blood clots (pulmonary embolism) as well as leg blood clots (deep venous thrombosis-DVT).
“These technologies involve expressing the genes for the therapeutic proteins in different microbial hosts like bacteria and yeasts. The latter include the well known baker’s yeast and Pichia pastoris. The cost advantage and ease of production of proteins have made the recombinant yeast based technologies prevalent worldwide which hold a major share of world therapeutic protein market,” said Jagmohan Singh, the Chief Scientist.
Singh has developed an indigenous technology platform for commercial scale production of Biotherapeutic Proteins to make these basic life-saving drugs accessible to the masses at cheaper costs.
The new system, which is based on Schizosaccharomyces pombe commonly known as fission yeast, has great potential to produce vaccines like Hepatitis B surface antigen vaccine (HBS) and other therapeutic proteins at a lower cost than that produced in Pichia. This technology can be extended to produce other proteins, like Erythropoietin, antibodies, etc.
The current cost of hepatitis B vaccine in India ranges from Rs. 45 (Serum Institute) to Rs. 250 per paediatric dose of 10 microgram in 0.5 ml. In USA it is about $25 per dose. The cost of adult dose of 20 microgram is nearly double. The normal regimen of vaccination involves 3 such injections. The indigenous technology would bring down the cost to less than Rs. 10, when commercially produced.
India has over 40 million Hepatitis B infected patients, second only to China.
Most Hepatitis B patients are unaware of their infection, putting them at serious risk of developing cirrhosis or liver cancer, which is life-threatening.
Similarly, the price of insulin varies from Rs. 140 to Rs. 325/- per injection in India, while in USA it is about $13 per injection. The slow release variant of insulin called Glargine costs from Rs. 410 to 1475 in India and $250-$275 for a 10 ml vial in USA and Canada.
This would be brought down to a third, once the technology developed by IMTECH is commercialised.
“So far we have expressed hepatitis B vaccine at bench scale in fission yeast. Once the production is scaled up, the production cost could be around Re. 1 per dose, while the lowest cost reported for Pichia-based system Rs. 45/- dose,” Singh said.
Adding, “Even this is beyond the reach of people below poverty line. Thus, there is scope to bring the commercial price of Hepatitis B vaccine further down. Once the proof-of- concept stage is complete, we will undertake expression of other proteins like insulin, antibodies, etc in fission yeast.”
The worldwide market of recombinant Hepatitis B (HBS) vaccine is more than US$ 3.2 billion. The market for anticancer monoclonal antibodies is even bigger and growing.
However, most of the technologies or products are imported. Furthermore, currently popular system of Pichia is patented. This implies payment of large fees by the Indian Biotech companies to the inventor, which adds to the cost of the vaccine.
Pichia vector is generally licensed for commercial research for USD 50,000 with an annual maintenance fee of $ 5,000-30,000. In case the product is commercialized the fee is $75,000 plus royalty ranging from 3-5%,” he said.
“While providing protein drugs at lower cost, it would also be a money generator if the technology is commercially exploited worldwide. This is a timely invention as Indian Biotech Industry is poised to enter the multibillion dollar market of biosimilar therapeutic proteins,” he concluded.