MHRA-approved cleanroom facility opens at R5 Pharmaceuticals
R5 Pharmaceuticals can now offer services to develop sterile investigational products. Its state-of-the-art cleanroom facility has opened following approval from the Medicines and Healthcare products Regulatory Agency (MHRA).
The new facility can be used for aseptic, terminally sterilised and freeze-dried products. As opposed to isolator-based systems, the R5 facility comprises large, walk-in spaces to avoid restrictions and allow sufficient room for projects to be completed easily.
The R5 cleanroom facility is specifically designed to cater for Phase I and Phase II investigational medicinal products. It is not designed for commercial scale and scheduling is therefore reserved exclusively for the R5 customer base: pharmaceutical/bio development projects for early clinical phases. The new cleanroom facility is managed by John Seagrief, formally of AstraZeneca.
‘There are very few organisations that have this cleanroom capability, which sets us apart and marks an important development for R5 Pharmaceuticals,’ said Paul Titley, ceo of R5 Pharmaceuticals. ‘The new cleanroom means we can provide our customers with a dedicated, comprehensive manufacturing service for developing investigational medicinal products.’
R5 Pharmaceuticals, an integrated formulation and development company, launched its comprehensive range of contract services in drug development for the pharma and biotech industry in March 2007 and has clients in the US as well as EU and non-EU countries.
Based on the BioCity campus in Nottingham, UK, the company offers an integrated approach to pharmaceutical development, from drug formulation and delivery technology through to full-scale manufacture.