Scotland has cemented its reputation as an international hub of stem-cell research with the launch by Dundee-based ITI Life Sciences of a £9.5 million programme to develop an automated process for the production of high-quality human stem cells. The announcement comes hard on the heels of another local initiative involving stem-cell science, the US$114 million Scottish Centre for Regenerative Medicine in Edinburgh.

According to ITI, one of three Intermediary Technology Institutes (ITIs) established as operating divisions of ITI Scotland Ltd, a “robust and scaleable” technology for generating human stem cells “does not exist anywhere in the world”. Under a three-year programme, ITI is teaming up with the University of Glasgow and Swedish biotechnology company Cellartis, which is setting up a R&D and manufacturing facility in Dundee with the help of a £1.2 million grant from investment agency Scottish Development International.

The university will contribute expertise in the molecular mechanisms that control cell signalling and development, through its Faculties of Medicine and Biomedical and Life Sciences. Cellartis brings to the table its existing portfolio of defined human embryonic stem (hES) cell lines, 20 of which are listed in the UK Stem Cell Bank. The company says it is the world’s largest single source of ethically derived hES cell lines, with more than 30 well-documented lines developed to date and a focus on quality and production scale-up.

ITI hopes these combined capabilities will find a way over the two main technical hurdles to more extensive use of stem cells as tools in drug development and, eventually, novel disease therapies: finding a reliable process for generating large volumes of stem cells; and controlling the way in which undifferentiated stem cells change into more specific body cells (e.g., heart cells). Working on pre-existing hES cell lines, the ITI programme aims to develop a robust and standardised procedure for generating multiple human cell lines of interest to the pharmaceutical industry from undifferentiated hES cells. Any associated intellectual property will belong to ITI Life Sciences.

Market worth $1.4bn in 2001, growing apace

According to ITI, the market for cell-based tools within the pharmaceutical industry was worth an estimated US$1.4 billion in 2001 and has “grown at a considerable rate ever since”. There will also an opportunity to expand on the first phase of the collaborative programme if certain milestones are reached. ITI described the initiative as “highly complementary” to work planned at the Scottish Centre for Regenerative Medicine, which is expected to be up and running in 2010.

ITI Scotland was set up in 2003 by Scottish Enterprise, with support from the Scottish Executive, to bridge the gap between publicly funded early-stage research and privately backed commercial development in three key sectors: life sciences, energy, and digital media/communications. Projects already underway at ITI Life Sciences include a £30 million programme to develop near-patient and home-use diagnostic tests based on cardiac biomarkers; and a £5.5 million investment in transgenic screening and safety models for early drug development.