Cell therapy manufacturing in Scotland
Scotland has an established base of regenerative medicine companies and collaborations – and thanks to the development of a new cell manufacturing facility, it’s becoming even stronger.
Emily Petrides, life sciences international senior executive for Scottish Development International, explains how Scotland is leading on cell therapy manufacturing.
As innovations in disease treatment progress from small molecule pharmaceuticals to biologic therapeutics and on to cell and gene therapies, it will become increasingly important to work with expert facilities capable of manufacturing these complex Advanced Therapeutic Medicinal Products (ATMP).
Scotland has established a strong research base in regenerative medicine, complemented by expertise in cell therapy clinical trials and an integrated academic, clinical and commercial infrastructure. This is currently supported by a network of early phase Good Manufacturing Practice (GMP) manufacturing centres in Scotland and the rest of the UK.
New cell manufacturing facility
The completion of TC BioPharm’s new cell manufacturing facility in Glasgow’s BioCorridor will help meet the growing need for clinical manufacturing in Scotland.
TC BioPharm’s clinical facility is the second facility for manufacturing clinical grade cellular therapies in Scotland designed to support their γδ T cell immunotherapy and other pipeline products. It joins the Edinburgh BioQuarter-located ATMP cGMP manufacturing facility run by Roslin Cells.
The TC BioPharm facility has been constructed to comply with MP regulations and includes offices, two cleanrooms, quality control suites and development laboratories. The Roslin Cells facility can run 12 open and nine closed clinical projects each year in conjunction with the Scottish National Blood Transfusion Service.
A global leader in clinical trials
Scotland is a proven global leader in supporting and implementing cell therapy clinical trials. We already have two stem cell therapies in routine clinical practice, and there are an additional six clinical trials in stem cells actively ongoing.
For example, ReNeuron’s PISCES study (Pilot Investigation of Stem Cells in Stroke) was conducted in Scotland at the Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board. The company is currently setting up its Phase 2 study, and the stem cells for the study will be manufactured by Roslin Cells. Additionally, Roslin Cells will be manufacturing retinal pigment epitheliun cells for the Pfizer Inc cell therapy clinical trial for the treatment of patients suffering from age-related macular degeneration.
How we can help
Scottish Development International can help you take advantage of the ongoing research, manufacturing, partnerships and clinical studies in Scotland to help you develop your stem cell technologies in the EU.
Support for regenerative medicine in Scotland