Qualified Persons Requirement for the University of Birmingham

The University of Birmingham is a world-leading institution for the generation of pre-clinical breakthroughs, delivery of clinical trials, and associated health and methodological research. Its advantages stem from close integration with nearby NHS Trusts, particularly with its key partner the University Hospitals Birmingham NHS Foundation Trust (UHBFT). It has access to one of the largest and most diverse patient catchment regions in Europe, alongside a wide range of well-characterised patient cohorts. Capabilities and expertise in advanced therapies are based around excellent under-pinning basic science, good pre-clinical models of disease, manufacturing facilities, translational facilities and clinical trials expertise.

The University of Birmingham and University Hospitals Birmingham jointly host significant infrastructure for experimental medicine and early phase trials including the millennial Wellcome Trust Clinical Research Facility, the Experimental Cancer Medicine Centre and NIHR Biomedical Research Unit for Hepatology. The BCCT hosts the Early Drug Development team with expertise in industry-sponsored and academic-led trials, adult and paediatric oncology, solid cancers and haematology, liver medicine, molecularly targeted therapy, cellular immunotherapy and gene therapy. It has dedicated, integrated and expanding facilities for clinical assessment and treatment, whole body metabolic measurement, pharmacy, imaging and GCP-compliant laboratories.

The Advanced Therapies Facility (ATF) is situated within the College of Medical and Dental Sciences, and comprises the Human Biomaterials Resource Centre (an HTA licensed ethically approved human sample repository) and the GMP Manufacturing Facility (GMP-MF). The GMP-MF holds a Manufacturer's Licence from the MHRA which covers the production of Advanced Therapy Medicinal Products (ATMPs) within the Cell Therapy Suite (CTS) and faecal microbiota within the Microbiome Treatment Centre. In addition, a Specials licence allows for the manufacture of products for use for selected patients outside clinical trial settings. The unit has a robust personnel and governance infrastructure with a dedicated team who can provide expertise and advice on protocol development, and who deliver all aspects of technology transfer, process validation, manufacture and Quality Control.

Within the CTS there are two parallel clean room suites cascading from Grade D through to Grade B classification. Grade B areas contain Class 2 safety cabinets or isolators. The facility also contains state-of-the-art cell sorting technology including CliniMACS and Prodigy systems, a dedicated QC laboratory, and ample GMP compliant storage areas containing freezers and liquid nitrogen tanks. The unit is joined onto the adjacent NIHR/Wellcome Trust Clinical Research Facility where manufactured products are administered to patients in an appropriately staffed and monitored clinical environment.

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Is a Recurrent Procurement Type? : No