Overview

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:

Suite 1
Grade B processing room and 2 Grade A MSCs
Shared grade C support room.

Suite 2
1 Grade B processing room + 2 Grade A MSCs
1 Shared Grade C support room.

Suite 3
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.

Manufacturing Capability

• 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)
• Fill/finish
• GMP cryogenic storage

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.

Licenses Held

MHRA MIA IMP 45803
MHRA Specials 45803
HTA 22631

Team

CEO: Janet Downie
Manufacturing Manager: Kim Cuthbert
Cell Therapy Development Manager: Lindsay Fraser
QP: Bruce Cuthbertson

Address

RoslinCT Headquarters
Nine Edinburgh Bioquarter,
9  Little France Road,
Edinburgh,
EH16 4UX

RoslinCT GMP Manufacturing Facility
Roslin Cells Limited,
Scottish Centre for Regenerative Medicine,
5 Little France Drive,
Edinburgh,
EH16 4UU

Contact

Janet Downie, Chief Operating Officer
janet.downie@roslincells.com
0131 658 5182

Fiona Bellot, Business Development Manager
fiona.bellot@roslinct.com
0044 131 658 5189