Transforming the Future Together
We offer a communicative, collaborative approach to working with our partners to meet project milestones, solve problems that may arise, and deliver on time. Together with our partners, we strive to provide life-saving therapies to patients worldwide.
Cell Therapy Services Delivered with Passion
High-quality Standards to Meet Your Regulatory Expectations
Our Quality Management Systems (QMS) and Quality Control (QC) programs have been developed to ensure product quality while offering the flexibility needed to support manufacturing for all phases of development and commercialization.
Cell Therapy Services Delivered with Passion
Extensive Expertise in Cell Therapy
We offer a comprehensive range of services, including process development, analytical testing, clinical and commercial cGMP manufacturing, and cGMP iPSC cell line development, gene editing, and differentiation. These services will empower advanced cell and gene therapy developers to advance their products through clinical trials and bring them to market.
Cell Therapy Services Delivered with Passion
Purpose-built cGMP Manufacturing Facilities
State-of-the-art, purpose-built cGMP manufacturing facilities and process innovation/development laboratories. 22 cGMP cleanrooms across two continents (North America and Europe) to support US & EU clinical & commercial production.
Cell Therapy Services Delivered with Passion
Innovative Platform Technologies
We are committed to assessing and offering innovative processing and analytical platforms to enable the delivery of cost-effective, compliant cell-based therapies to patients in need, and maximize the potential of our partners’ projects.
As one of the first in the world to produce clinical-grade human pluripotent cells, we have extensive experience with a range of reprogramming technologies, gene editing, expansion strategies, and all aspects of quality control testing.
Our broad development experience across multiple cell types will empower our partners to accelerate their development timelines, improve manufacturing efficiency, and enhance product quality.
RoslinCT’s established MSAT capabilities and process ensure a smooth standardized approach to knowledge transfer from the partner to establish a foundation for further development optimization, and cGMP manufacturing.
RoslinCT offers transatlantic cGMP manufacturing capabilities to support both clinical and commercial needs meeting global regulatory requirements. The 22 cGMP processing suites are purpose-built to support autologous and allogeneic-based products.
At RoslinCT, our cell therapy Supply Chain team collaborates with our partners to manage materials and logistics with patients in mind. With facilities in the UK and the US, we offer fast and secure global distribution of your cell-based products.
Our Pharmaceutical Quality Systems (PQS) have been developed to meet US and EU regulatory standards for cell therapy products while offering the flexibility required to support clinical and commercial manufacturing.
RoslinCT’s experienced project management team utilizes standardized processes and advanced technology to enable our partners’ success.
We provide our partners with a leading-edge platform that combines innovative technology and know-how expertise
Drawing on a rich heritage and expertise, RoslinCT brings together a legacy of groundbreaking achievements. RoslinCT traces its roots back to the historic cloning of Dolly the Sheep at the Roslin Institute within the University of Edinburgh (UK) in 1997, which garnered worldwide interest. RoslinCT was established in 2006 to translate this cutting-edge science and apply it to the development of human medicines.
RoslinCT, as one of the first in the world to produce clinical-grade human pluripotent stem cells, has a strong focus on science and innovation. In collaboration with Vertex Pharmaceuticals, RoslinCT is supporting the development and future commercialization of the First CRISPR-Edited Cell Therapy Product, exa-cel for the treatment of sickle cell disease and transfusion-dependent beta-thalassemia.
RoslinCT is an organization that is committed to assessing and offering innovative processing and analytical platforms for cell therapy manufacturing. This is achieved through partnerships with academic institutions and industry-leading process solution providers to identify and beta-test optimal cell therapy tools and platforms.
Our facilities have been built for maximum flexibility. Suite sizes vary, with smaller suites that are suitable for individual patient material processing and larger suites that can accommodate allogeneic processes at higher volumes.
Suites may be dedicated or shared, and suite layouts can be changed to accommodate our partners’ manufacturing processes.
Our QMS and logistics processes cover all scenarios, from fresh-in/fresh-out autologous processes through large-scale allogeneic processes and RoslinCT offers cryopreservation services for products that can be stored for future use.
Our facilities have been specifically designed for the appropriate segregation of concurrent manufacturing activities. The flow of materials is designed to prevent mix-ups and avoid contamination.
Handling of the patient starting material is governed by specific processes and procedures with additional considerations for ensuring COC and COI, clinical study-specific labeling, inbound and outbound expiry, and logistics, segregation, and environmental controls.
The patient material is issued a product-specific COI number at the time of scheduling. COC and storage conditions are tracked and maintained throughout.
The patient material is received through an access-controlled location, inspected and released into the facility. Established procedures and electronic systems ensure that COI and COC are maintained at all times.
Upon the initialization of processing, the patient material is transferred from the receiving/inspection location to the incoming Patient Materials Room where it is prepared for cleanroom entry, and the COI is once again verified. The patient material is then transferred to the assigned processing suit.
RoslinCT intentionally refers to its manufacturing facilities as “purpose-built” because the layout of the facilities, from the ground up, was specifically designed for the efficient and compliant production of cell and gene therapy products.
In the facility planning process, RoslinCT’s highly experienced architectural and engineering team considered all aspects of a cell therapy operation including people, process, and material flows in line with global regulatory requirements. In addition, our extensive use of sophisticated, state-of-the-art software platforms facilitates the real-time transfer of data, reduces errors, and enables electronic batch records that ultimately enable real-time testing and release of the final product.
