External Quality Control Testing (for Cellular and Molecular Therapies)

NHS Blood and Transplant is seeking to engage with the market in relation to the provision of external Quality Control testing services to support the Clinical Biotechnology Centre in the development and production of Advanced Therapeutic Investigational Medicinal Products, biotechnology products and biological products. The requirement is expected to include specialist QC testing services for in-process, final product and cell bank testing, with testing capabilities potentially including mycoplasma testing, bacterial cell bank testing, mammalian cell bank testing, specialised viral safety testing, viral clearance studies, sterility testing and cell-based sterility testing. The precise testing requirements may vary by project and NHSBT may require the ability to add or remove tests during the contract term. Suppliers would be expected to operate under appropriate regulatory and quality standards, including GMP and, where applicable, GLP, and to provide validated assays, appropriate quality documentation, Certificates of Analysis, comprehensive reports, support for quality technical agreements, audit access and out of specification investigations.