RoslinCT is a UK-based contract manufacturing organisation focused on providing tailored process development services and robust GMP manufacturing solutions for companies developing cell-based therapeutics for clinical trials.
The GMP manufacturing suites consist of 250m2 cleanroom space, QC suites, technology transfer suites, raw material and final product storage.
Cleanroom space consists of:
Grade B processing room and 2 Grade A MSCs
Shared grade C support room.
1 Grade B processing room + 2 Grade A MSCs
1 Shared Grade C support room.
1 Grade C processing room
Custom built cell therapy isolator.
RoslinCT has technology transfer and process scale-up facilities with experience in the development of closed and automated processing methods. The QC laboratories offer microbiological, genomic and flow cytometry services to support clinical product release.
- GMP translation
- Process scale-up
- Assay validation
- In-process testing
- Identity, safety and final product release testing
- GMP technology transfer
- GMP process validation
- GMP clinical batch manufacture
- Cryopreservation (controlled rate freezing)
- GMP cryogenic storage
- Adherent cells
- Bulk allogeneic processes
- Gene modified cells
- Human embryonic stem cells
- Patient specific processes
- Suspension cells
- T cells
- Tissue processing
Roslin Cells Ltd was formed as a spin out from the Roslin Institute in 2006. By 2013 the company had been awarded both its HTA and MHRA licences, allowing for the production of ATMP’s in the custom built GMP Facilities. During this time, the company positioned itself as a pioneer in hESC derivation, differentiation and characterisation and became the first European company to successfully establish a GMP grade hESC line. The company also aided in the establishment of the first European cell bank for induced pluripotent stem cells (EBiSC).
In 2015, in order to focus exclusively on delivery of its GMP contract manufacturing services, Roslin Cell Therapies Ltd was formed (now trading as RoslinCT). RoslinCT is an established leader and a reliable partner for the development, optimization, scale-up and GMP manufacture of cell-based therapeutic products. RoslinCT has successfully released a range of GMP products from cell banks to drug products for clinical use.
MHRA MIA IMP 45803
MHRA Specials 45803
CEO: Janet Downie
Manufacturing Manager: Kim Cuthbert
Cell Therapy Development Manager: Lindsay Fraser
QP: Bruce Cuthbertson
Nine Edinburgh Bioquarter,
9 Little France Road,
RoslinCT GMP Manufacturing Facility
Roslin Cells Limited,
Scottish Centre for Regenerative Medicine,
5 Little France Drive,
Janet Downie, Chief Operating Officer
0131 658 5182
Fiona Bellot, Business Development Manager
0044 131 658 5189
Location & Website
The facilities on this site took part in a survey in 2011 and have subsequently confirmed their license status.
If you are the manager of a facility licensed for ATMP manufacture in the UK, not included on this site and would like it to be please email firstname.lastname@example.org