CSIR-IMTECH’s KNOW-HOW ON RECOMBINANT STREPTOKINASE (rSK) – CSIR’s second-generation clot buster
After the introduction of natural streptokinase in the market in the year 2002, the IMTECH team continued to work in this area and soon thereafter developed a facile process to manufacture a recombinant version of natural type streptokinase which is roughly ten times efficient as the natural SK production technology. This was expected to still lower the price of the life-saver clot-buster drug.
Best in the country/world:
The most notable point regarding IMTECH’s rSK production technology is that the yield per unit of culture-volume is several times higher than that for the natural system developed at IMTECH previously.
In addition to the above-noted scientific developments relating to high-level intracellular expression, the process for rSK (intracellular) production involves a highly optimised two-chromatographic step down-stream scheme capable of overall yields of around 70% of highly purified (>98% purified) rSK. Fermentation at high cell densities is also an integral upstream step in the production process for rSK. The process yields approx. 0.8 to 1.0 gram of purified rSK per litre high density culture (equivalent to ~ 60 therapeutic doses per litre of fermentation liquid). The purified rSK shows biological activity that is comparable to highest purity natural SK (~1.0 x 105 IU/mg protein).
The technological package (recombinant clones, fermentation parameters and down-stream processing to obtain drug-quality product)) was successfully transferred in the year 2002-03 to a leading drug industrial house, namely M/S Shasun Chemicals & Drugs Ltd., Chennai which specializes in bulk drug manufacture.
The product was launched for the Indian markets on July 10, 2009 under different brand names which are given below:
Pharma Company Brand Name
Gland Pharma GlanikinaseTM
United Biotech StreptonaseTM
This technology, introduced in the market, is expected to further bring down the prices significantly and make this vital life-saver drug available to even the most economically challenged consumer at affordable costs. Most recent updates indeed suggest that the drug has been received very well by the market as is apparent from the regular royalty payments received by IMTECH.
Marketing of CSIR-IMTECH’s rSK API under various brands
The value creation by natural and recombinant streptokinase for the nation is nearly Rs. 20,000 crores to the people of India.
IMTECH’s rSK BEING LAUNCHED ON JULY 10, 2009
Recently in September 2013, IMTECH had also licensed this technology of recombinant streptokinase to Epygen Biotech Pvt. Ltd., Mumbai on non-exclusive basis. The value of licensing was Rs. 4.00 Crores (Milestone Payment) plus royalty.