RoslinCT

Overview

RoslinCT is a contract development and manufacturing organization (CDMO) focused on advanced cell and gene therapies. The company works with therapy developers to move complex cell therapy processes from development into phase-appropriate, cGMP-ready programs across immunotherapies, gene-edited therapies, and stem cell/iPSC platforms.

Capabilities

• cGMP iPSCs: One of the first organizations to produce clinical-grade human pluripotent stem cells.
• Process and analytical development: Process and Analytical Development Laboratory supporting cell therapy programs.
• cGMP cell banking: Cell bank production.
• Manufacturing science and technology: Technology transfer and manufacturing strategy advice.
• Clinical and commercial manufacturing: Autologous and allogeneic manufacturing using flexible suite design, closed processing, chain-of-identity controls, and tailored release testing.
• Quality and regulatory compliance, supply chain and logistics: Listed as service areas on the company website.

Track record

RoslinCT collaborated with Vertex Pharmaceuticals, from early process development through commercialization, on exa-cel, described on the site as the first CRISPR-edited cell therapy product, for sickle cell disease and transfusion-dependent beta-thalassemia.

The website reports more than 500 cGMP batches produced for various indications, more than 22 cGMP suites allowing simultaneous processing, and experience with more than 20 cell types supporting autologous and allogeneic processes. The company states it has been recognised in The Sunday Times Scotland Fast 50.

Facilities and footprint

RoslinCT describes purpose-built cGMP manufacturing facilities. The company also reports the acquisition of a large facility in Boston, which it says expanded its services and transatlantic cGMP manufacturing capability. The website also references US and UK leadership roles, including Head of Quality (US) and Head of Quality (UK).

Positioning

RoslinCT traces its origins to the Roslin Institute at the University of Edinburgh and describes itself as an advanced CDMO partner for cell and gene therapy developers moving programs from development to commercialization.