The GSTT expertise and offering for advanced therapies alongside King’s College London (KCL), the academic and Advanced Therapy Treatment Centre (ATTC) partner of GSTT, is well established and highly reputable. Infrastructure spans the end-to-end requirements from process development ahead of manufacturing through to clinical trial delivery, including trials of first in human studies. In partnership with KCL, the Advanced Therapies Accelerator, established in 2021, is core infrastructure supporting the development of advanced therapies providing for advanced cytometry services, genomics services, dedicated development space for non-commercial collaborative research and an innovative solution for commercial entities to work with GSTT, KCL and / or Catapult to collaborate through leveraging expertise in the development and process development for advanced therapies.

Within GSTT, the Advanced Therapies Good Manufacturing Practice (GMP) manufacturing unit has been undertaking process development and manufacturing of cell therapies for clinical trials since 2012 including chimeric antigen receptor- T (CAR-Ts), regulatory- T (T-Regs) cells and Mesenchymal Stromal Cells. The unit also handles all commercial trial cell therapy products from receipt from the trial sponsor through to handover to the trial delivery team. The Advanced Therapies GMP unit is near completion of an expansion in the number of clean rooms and supporting infrastructure. Two new Class B clean rooms will increase capacity for cell therapy manufacture from the current three Class D clean rooms.

KCL has vector manufacturing infrastructure (the Gene Therapy Vector Facility) for gene therapies capable of manufacturing lenti-and retro- viruses and is in the process of developing a new facility for the manufacture of Adeno-associated viral vector.
Fundamental to translating advanced therapies to the patient is the infrastructure to deliver clinical trials. GSTT provides one of only 3 in the UK, Phase 1 Medicines and Healthcare products Regulatory Agency (MHRA) accredited Clinical Research Facilities (CRF) at Guy’s Hospital, specialising in early phase and advanced therapies trials. The CRF is co-located alongside the Advanced Therapies GMP manufacturing unit allowing for seamless coordination of non-commercial manufactured and commercial trial product between the GMP unit and the patient within the CRF.

Furthermore, GSTT has an established apheresis unit within Guy’s Hospital allowing for the collection of starting material from patients for subsequent autologous cell therapy manufacture whether manufactured within the GMP unit or by the commercial trial sponsor.
The Evelina Children’s hospital hosts the paediatric unit of the CRF across two wards specialising in the delivery of research across all trial phases, including trials for advanced therapies, rare diseases and neonatal research. The Royal Brompton Hospital is the site for the CRF Cardiorespiratory unit and has rapidly become key infrastructure for the delivery of early phase gene therapy studies in both cardiac and respiratory disease.

GSTT, through its specialist infrastructure and workforce, are highly experienced in delivering advanced therapy trial products to patients, has conducted a broad range of advanced therapy clinical trials across a number of disease indications, and gene and cell therapy modalities. Trials for cell therapies in oncology, transplantation, COVID and Inflammatory Bowel Disease have all been carried out within the GSTT infrastructure while gene therapy trials have target conditions such as Haemophilia, Cystic Fibrosis and heart failure. Numerous mRNA based advanced therapies for infectious disease and oncology have also been delivered across the trials.