CCTech is pleased to have contributed to the delivery of the new Cell Therapy GMP Facility at Guy’s Hospital.
This project represents a significant milestone in enhancing specialist healthcare infrastructure within Guy’s and St Thomas’ NHS Foundation Trust (GSTT). The facility is world leading in its research and this significant advancement has been made to address the increasing demand for the clinical trial manufacturing of cell and gene therapies, in collaboration with the NIHR Maudsley Biomedical Research Centre at King's College London.
The facility, commonly referred to as the CRF GMP Unit, is a purpose-built environment dedicated to the production of Investigational Medicinal Products (IMPs) and Specials for use in clinical trials. Already recognised as a leader in the manufacturing of regulatory T-cell immunotherapy, the unit is now expanding its capabilities to support a wider range of advanced therapies, including stem cell-derived photoreceptors and adherent cell products.
We provided GMP technical support from initial concept through to completion, overseeing construction at all stages and offering guidance to the construction team, vendors and the end-user team. Our responsibilities included managing validation activities and providing practical operational and process advice to facilitate MHRA licensing.
As with most projects, there were some challenges, particularly concerning the building footprint and the availability of utilities. However, we successfully addressed these issues in a compliant manner, providing technical guidance and support to end-user teams as subject matter experts during MHRA inspection. We successfully secured MHRA approval on the initial inspection.
It was a pleasure to work with such an initiative-taking project team and end-user team, with thanks to Lexica WSP & Scitech-EKIUM.
Located on the 15th floor of Guy’s Hospital, this state-of-the-art facility features:
- Two Grade B Cleanrooms
- A new QC Laboratory and Cryo-Storage area
- Ancillary spaces, including a dedicated plant room
Designed to support advanced cell therapy research and treatment, this GMP-grade B environment will enable the development of innovative therapies with the potential to treat and even cure conditions previously deemed untreatable. The complexity and design of the facility presented considerable challenges, which underscore the recognition awarded for Best Cleanroom Design at the Cleanroom Technology Awards 2026.
Our scope included:
- Change management principles and co-ordinated stakeholder alignment, communication strategy and document control
- Technical and GMP compliance advice throughout the project
- Generation of Validation Life Cycle Documentation
- DQ & IQ execution, including resolution of any deviations
- Validation Summary Reports collation
- Subject matter experts supporting audit
- Preparation for, and on-site support with, the MHRA Inspection