ESI has focused on the creation of a robust platform that allows for the scale-up of hES cells and, specifically, differentiated cells, their stable transplantation into human patients, and the identification of the growth factors that are essential to the maintenance and differentiation of these stem cells.
The genes and their products can be developed as either growth factors or reagents to grow specifically differentiated cells for cell replacement therapies. Its first therapeutic application will be in the treatment of diabetes through the conversion of hES cells into islet cells. The company plans on beginning clinical trials in 2006.
Additional clinical applications involve neurology for the treatment of degenerative diseases (such as Parkinson's) and cardiology through the use of heart cells to repair damaged heart tissue resulting from myocardial infarction. There is also an interest in hematopoiesis as an approach to the treatment of leukemia.
Development of hES cell lines would take place in Singapore along with scale-up production. Clinical trials would then be carried out in Singapore, the U.S., and Europe. Appropriate treatment centers would then be established where diagnosis, treatment and follow-up would take place.
Cordlife, a company founded in 2001 in Singapore, is another firm targeting stem cell technology. Cordlife's core business is the collection, processing, and storage of umbilical cord stem cells. This allows the transplanted cells to be perfectly matched to the patient.
In principle, there are some 72 diseases that could be treated through the transplantation of such cord stem cells. This does require an efficient and reproducible process for large scale production.
Cordlife took the route of merging with Cytomatrix (Cambridge, MA). The basic premise was that the optimal growth of mammalian cells required a 3-D orientation. Cytomatrix developed a carbon skeleton structure coated with metals at high temperature and functionally resembling bone marrow.
With support from EDB, this system is being used for the efficient growth of stem cells. The company is establishing a regional network of stem cell treatment centers. The Cambridge laboratories also are exploring alternative sources of stem cells (such as adipose tissue).
A-Bio Pharma was founded in 2002 as a spinoff from the Biopro-cessing Technology Center. The company is a custom contract manufacturing entity dedicated to the production of biologicals, which includes biological therapeutics, monoclonal antibodies, and vaccines. A-Bio is fully owned by Bio-One, the EDB venture capital arm.
At present there are some 500 biological products that are going through the various stages of clinical trials. It is estimated that U.S. demand for biologicals will grow at an annual rate of 12%, reaching a market value of $56 billion in 2006.
The design, construction and regulatory approval of production facilities for biologicals is lengthy, which is likely to lead to a shortage of biologicals manufacturing capacity worldwide. Contract manufacturing companies are expected to fill this gap.
A-Bio has a staff of ninety recruited from all over the world. Their current facility allows small-(up to 40 liters) and large-scale production (up to 500 liters). The current work focuses on maximizing cell culture growth and development.
A-Bio provides process development, production of clinical lots, analysis, and regulatory counseling. A-Bio plans to expand into a new facility that will house two 500-liter bioreactors.
One important milestone in this plan is the signing of an agreement with GSK Biologicals for the development and manufacture of clinical lots of GSK's promising new vaccines.
The past five years have seen the creation of a number of innovative biotech firms. All of them have been led by expatriates who have made a conscious decision to establish themselves in this island state.