New center to deliver GMP-grade stem cells
Edinburgh – Scottish scientists are well on the way to deliver clinical grade human stem cells to researchers and companies all over the world. “We will soon be able to deliver embryonic stem cells that meet the regulatory requirements,” Edinburgh-based researcher Paul de Sousa told EuroBiotechNews on the occasion of a EUR3 million kick-off funding for the new Roslin Cells Centre (RCC). “We aim to have our first research grade cell lines available for distribution in spring/summer 2007. In parallel we are developing GMP grade stem cells, which, pending UK Human Tissue Authority accreditation, would be compliant with UK and EU regulations for therapeutic use.” The RCC, which is funded by Scottish Enterprise Edinburgh, will be run by Roslin Cells Ltd, a not-for-profit company.
“What distinguishes us from other groups which aspire to produce clinical grade stem cells is that we co-operate with the National Scottish Blood Transfusion Service, who brings in a lot of experience in regulatory compliance. The other significant feature is that we are prepared to distribute cells to researchers or companies for upfront fees for either exclusive or nonexclusive use. Those fees will enable researchers to commercially expand their research without needing to negotiate commercialization licensing rights in the future,” says de Sousa. This could mean significant progress for the stem cell sector. Currently, all stem cell providers demand license fees on any commercial product derived from their stem cells. This could possibly hamper commercialization or the funding of stem cell discoveries. Whilst it is unclear if the European Regulatory Authorities will accept GMP-grade stem cells cultivated in media which contain animal-derived products, the RCC’s cultivation strategy will be diversified. “We will produce cell lines either with or without animal compounds to meet the regulatory requirements.”