RLS officials said the facility for therapeutic proteins would be one of the most modern, and the largest in South Asia. They, however, declined to divulge details pertaining to the cost and capacity of the project.
The plan for a therapeutic proteins unit follows the successful commissioning of the stem cell-enriched cord blood repository by RLS in June 2002. The company claims that the repository is the first in the umbilical cord blood segment to be granted a licence from the regulatory body.
Commenting on the capacity of the repository, sources said it was based on a bio-archive system, which was modular in nature and each system can store about 4,000 units. Currently, RLS has one such system and plans to add more units depending on the need, sources added.
Broadly, stem cells are blank cells that have the potential to develop into nerve cells, heart cells, kidney cells and the like in the body. Stem cells drawn from the donor are multiplied in the laboratory and induced in the body of the affected person by replacing the damaged cell.
According to analysts tracking the sector, the protocol for stem cells research in India has not been laid out well as compared to stringent norms in the US. Moreover, the cost of development of a new therapeutic recombinant protein in India is cost-effective, while the same in the US is estimated at around $500 million.
Meanwhile, RLS has already undertaken contact programmes with hospitals and clinics to enroll pregnant women into the voluntary donation programme of cord blood, in order to increase the number of samples in the repository.
The collected cord blood is screened for infectious disease markers, its HLA (human leukocyte antigen) is typed and then processed in terms of enrichment and volume reduction, filled in canisters, banked and stored in a bio-archive system.
The company has initiated a sibling donor programme and an allogenic programme as part of its repository. The sibling donor programme is meant for families with one child already suffering from blood diseases like thalassemia. Under the allogenic programme, needy patients provide their requirements for stem cells-enriched cord blood.
It is essential that the HLA of the donor and the patient be matched. Under the allogenic programme, the patients HLA is typed and matched with the stored stem cells-enriched cord blood samples through a database. After the match is established, the patient is provided the stem cells-enriched cord blood for transplantation.
Under the sibling donor programme, the cord blood of the child is collected, processed utilising the same processes as for the allogenic programme and then provided to the transplant physician.