Mikrobioloogilise testimise nõuete raamistik

Centre for Process Innovation (CPI) have existing GMP facilities at the RNA Centre of Excellence (CoE) in Darlington. To support this site, Microbiological testing services are required, including but not limited to Bioburden and Endotoxin. This tender is to cover the Microbiological testing services required for release analysis of buffers, intermediates, drug substance (DS) and drug product (DP) at the RNA CoE. CPI has technology centres across the UK and aims to support clients and customers with innovation projects as well as provide manufacturing capabilities. CPI’s RNA CoE is a multi-million pound GMP facility based in Darlington in the Northeast of England and is the only UK-based site with the capability to develop and manufacture lipid nanoparticle encapsulated messenger and self-amplifying RNA vaccines and therapies ready for use in early-phase clinical trials. The aim of this tender is to establish preferred and CPI-approved suppliers for the full scope of Microbiology Testing requirements for GMP release testing. The manufactured products will be used for early phase clinical trials, therefore, supplier approvals and a Quality Technical Agreement will be required. It is expected that the vendor holds a GMP certificate issued by the MHRA. This tender will primarily be used for CPI’s RNA Centre of Excellence located at 3 John Williams Boulevard South, Darlington, DL1 1GL, although this tender may be used across other CPI sites should their requirements fall under the scope of this tender