The Cell Therapy Suite (CTS) is a clean room facility licensed by both the MHRA for the manufacture of Advanced Therapeutic Medicinal Products (ATMPs), and the HTA for the production of cell- and tissue based therapies for human application. The main objective of the CTS is to enable, embed and facilitate clinical research projects and programmes involving the delivery of gene and cell-based therapies.
It is the only facility of its kind in the West Midlands and just one of a few across the UK. Comprising flexible space at grade C with two grade B processing rooms equipped to accommodate a variety of manufacturing protocols, including dedicated containment space for the genetic manipulation of cells.
We are a dedicated team of scientists with considerable combined experience in process development and delivery of ATMPs in clinical trials. Our facility houses the latest technology for the manipulation of cells for therapeutic use and our grade B cleanrooms are designed to be adaptable to a variety of projects.
We will work with you to take your project from the laboratory, through process development to full clinical stage manufacturing in accordance with Good Manufacturing Practice (GMP).
The CTS is a manufacturing partner in the Midlands-Wales Advanced Therapy Treatment Centre (ATTC). This Innovate UK funded ATTC Network Programme is a world-first and is set to establish a UK system of ATTCs, operating within the NHS framework and coordinated by the Cell and Gene Therapy Catapult, that will address the unique and complex challenges of bringing pioneering ATMPs to patients.
We work closely with academic investigators from around the UK, as well as global commercial clinical stage biotech companies, to bring clinical trial investigational medicinal products and cell- and tissue-based therapies to patients around the UK.
In association with the Midlands-Wales ATTC, the CTS has established links with key organisations in the ATMP field, from providers of manufacturing equipment and materials, through to logistics partners and NHS clinical research centres.
Licensed by the HTA and MHRA, we can provide vein-to-vein solutions for autologous and allogeneic ATMPs, including dedicated quality control and cryogenic storage areas. Furthermore, whilst we can provide access to key platforms for the closed processing of cell therapies, the flexible nature of our facility means we can install manufacturing equipment to suit a project as required. A dedicated GMO compliant area permits the generation of gene modified cell vaccines, such as CAR-T cells.
Working closely with the University of Birmingham Clinical Trials Units, we can deliver clinical trials from regulatory submission to close. Qualified Person (QP) support is available throughout this lifecycle from trial application to ATMP manufacture, certification and release.
In addition to manufacturing capability, we are licensed for the storage and distribution of ATMP Investigational Medicinal Products for third party manufacturers and the procurement, testing, processing, storage and distribution of cell- and tissue based therapies falling under HTA regulations.
Current manufacturing activity under our MHRA Manufacturer’s Licence includes the generation of dendritic cells from autologous monocytes and the generation of allogeneic mesenchymal stromal cells. Pipeline projects include isolation and re-conditioning of circulating blood dendritic cells and isolation and expansion of regulatory T cells. Under our HTA human application licence we are providing a clinical service for the cryopreservation of ovarian tissue intended for autologous transplantation for the purposes of restoring fertility.