Microbiological Testing Services for GMP-Certified RNA Manufacturing

The Centre for Process Innovation (CPI) seeks qualified suppliers to provide microbiological testing services for their RNA Centre of Excellence (CoE) in Darlington. Required services include bioburden and endotoxin testing for release analysis of buffers, intermediates, drug substance, and drug product. The RNA CoE is a multi-million pound GMP facility and the only UK site capable of developing and manufacturing lipid nanoparticle encapsulated mRNA and self-amplifying RNA vaccines and therapies for early-phase clinical trials. Successful suppliers must: (1) hold GMP certification from the MHRA, (2) complete supplier approval and Quality Technical Agreement processes, and (3) meet all GMP release testing requirements. While the primary location is 3 John Williams Boulevard South, Darlington, DL1 1GL, approved suppliers may support testing across other CPI sites as needed. This is an opportunity to become a preferred vendor supporting cutting-edge RNA therapeutic development.