Stempeutics Research Pvt Ltd, a group company of Manipal Group, has achieved a major breakthrough in stem cell production technology with the manufacture of its Investigational New drug (IND) sourced from Mesenchymal Stem Cells (MSCs) derived from bone marrow of healthy donors. Using the IND, the company has commenced the placebo controlled double blind trials at Bangalore, Kochi, Hyderabad, Ahmedabad and New Delhi.
The company through its newly designed proprietary technology is able to achieve large scale expansion of MSCs at its cGMP compliant unit at Manipal near Mangalore. It can produce stem cell-based drugs for over 10,000 patients from a single healthy donor through the innovative technology. MSC has received considerable attention in biological research because of its self renewal capability and its ability to expand and trans-differentiate into many different cell lineages. In addition, MSCs are immune privileged and there are no ethical issues involved since it is derived from adult stem cells. To meet large scale bio-production and make the drug affordable, a fast MSCs expansion method was the need of the hour, BN Manohar, president, Stempeutics Research stated.
Having gathered information about the path breaking research and production efforts, Union minister for state science and technology, Prithviraj Chavan who was in Bangalore made a surprise call at the company to have a first hand comprehension of the development.
"Taking into consideration, the lack of a uniform approach for MSC culture and expansion, we designed a technology and manufacturing process by identifying an optimal culture media and the harvesting time. We also ensured an appropriate combination of cell culture containers - while maintaining its multi-lineage differentiation potential. Through this production research which has lasted for more than two years, Stempeutics has achieved its break through where by it can produce from a healthy voluntary donor, drugs required for more than 10,000 patients," explained Manohar.
According to Dr Ranjan Pai, MD & CEO, Manipal Education & Medical Group, the global market for Stem Cell therapies estimated US$20 billion by 2010. Adult Stem Cell therapy currently dominates the global stem cells market with a share of almost 58 percent. The current stem cell therapy market in India is valued around US$540 million. While the opportunity is good it is essential that cost of stem cell treatment becomes less so that it is affordable by a common man. It is essential to come out with innovative production techniques for up scaling and make therapy affordable, he added.