Alan Colman - US grants

DESCRIPTION (provided by applicant): The purpose of this application from ES Cell International Pte Ltd (ESI) is to develop the infrastructure to increase significantly the production of six human embryonic stem cell lines listed on the National Institutes of Health (NIH) Stem Cell Registry in order to distribute these cells as widely as possible to other stem cell researchers. ESI aims to distribute hES cells to researchers worldwide in order to significantly increase the pool of human embryonic stem cell researchers and therefore greatly increase the rate of discovery of potential hES cell derived therapies for some of mankind's devasting degenerative illnesses and injuries which are currently either poorly treated or untreatable. The potential of hES cell based therapies and research applications has been throughly described elsewhere and does not need to be restated here. ESI began distribution of cells for 2 cell lines (hES 3 and hES4- female and male), under a Material Transfer Agreement on September 11 and as at Dec 14, has distributed to 12 organizations. This has been achieved out of the research laboratory at Monash Institute of Reproduction and Development. The process is very labor intensive and there is currently neither laboratory infrastucture nor personnel to increase this production at Monash. It is also a significant disruption to the stem cell research program. ESI therefore wishes to establish a new laboratory staffed by scientists devoted to cell production under stringent quality control processes. It will also provide training to recipients and will be involved in basic research to improve culture conditions as well as characterizing the sixth and final hES line (at the time of submission of this application, 5 lines will be fully characterized). ESI aims to be able to increase production sufficiently to distribute aliquots or one or more cell lines to researchers to establish their own research programs at the rate of 20 shipments per month. This will represent a five fold increase from our current capacity. Clearly, as stem cell culture conditions improve (which is the topic of some of our applied research programs at Monash and Singapore), we would expect this production to significantly increase.

[unreadable] DESCRIPTION (provided by applicant): [unreadable] With support from the NIH, ES Cell International (ESI) has developed infrastructure necessary for the distribution of six human embryonic stem cell (hESC) lines listed on the NIH stem cell registry ES01-ES06 (HES1-6). ESI has shipped over 130 cryopreserved samples of hESC since September 2001 and the vast majority of our customers have successfully established hESC cultures in their labs. ESI is currently in late stage negotiations with a major research reagents company which will be responsible for the ongoing production, QC, marketing and distribution of these cell lines. In addition to our production and distribution activities, ESI conducts a range of applied research into the conditions required to maintain hESC in culture (ESIs platform technology). Our platform technology program broadly encompasses: optimizing various aspects of the existing hESC culture and cryopreservation conditions with a view to minimizing batch to batch variability; validating newly published hESC methods; and developing scaleable culture methods which will allow medium to large scale hESC production under cGMP and FDA compliant conditions. The purpose of this application for renewal of the research infrastructure enhancement award is: a) Under the management of a major research reagents company, to maintain and enhance the existing hESC production and distribution infrastructure. b) Within ESI, to maintain and expand the platform technology research program with a view to developing technically simple, reliable, inexpensive and efficient methods to produce hESC on a large scale under cGMP conditions [unreadable] [unreadable]