ThromboGenics NV, a Belgian biotechnology firm focused on vascular disease, says it has completed the technology transfer to Bharat Biotech International of Hyderabad, India, for the manufacture of THR-100, a novel variant of recombinant staphylokinase. THR-100 is a thrombolytic agent developed for the treatment of acute myocardial infarction and other vascular diseases, based on its ability to dissolve blood clots.
ThromboGenics had late last year announced the completion of a license agreement with Bharat Biotech to manufacture, develop and commercialize THR-100 as a replacement for established thrombolytics, such as streptokinase and urokinase, in developing countries. The compound has completed Phase II clinical trials in Europe for the treatment of AMI, and is expected to enter Phase III in India later this year.
Bharat Biotech will use its manufacturing capabilities, along with technological expertise acquired from ThromboGenics, to produce clinical-grade material for upcoming clinical trials. By absorbing the THR-100 manufacturing technology at different scales, while maintaining required yield and purity, the Indian firm has demonstrated its ability and capacity to produce this recombinant protein with the desired performance, quality and cost-effectiveness.
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