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BES carried out design, construction, commissioning and validation services to deliver three viral vector suites for a leading international contract development and manufacturing organisation (CDMO) providing biologics and pharmaceuticals.
The refurbishment project involved design and delivery of three grade C processing suites, each specified to contain a class 2 microbiological safety cabinet (MBSC). The new facility also comprised a dedicated Vaporised Hydrogen Peroxide (VHP) unit, a waste store, and a grade C cold store. The new cell bank along with the liquid nitrogen storage were located within a new brick faced, pitched roof extension to the existing facility. This time-critical project had to be delivered during the pandemic to enable covid-19 vaccine scale-up and manufacturing, without interrupting Business As Usual (BAU) in the adjacent areas.
Working closely with the client, our multidisciplinary team completed the project despite the social distancing and supply chain challenges of the COVID-19 pandemic. BES carried out all construction works without interrupting ongoing operations in live areas. Our dedicated team performed successful OQ (Operational Qualification), including particles, pressures, Dispersed Oil Particulate (DOP) tests and clean up rates. The final validation and PQ (Performance Qualification) was carried out by the client to enable full production to begin. BES provided a consistent team and an accountable critical path throughout the design and construction phases of the project with clarity on costs and timescales from the outset.
From the outset, the BES team understood our commercial and operational requirements and worked with us to design and programme the project around those needs.
The company’s experience in the pharmaceutical industry makes them ideally placed to deliver complex projects like this for the gene cell therapy sector. Their multi-disciplinary team not only worked collaboratively with us, but seamlessly with each other, for a joined-up and efficient approach. This was particularly important during a period when we are involved in development and manufacturing work of international importance for COVID-19 response. It’s extraordinary that, despite the challenges of the lockdown, BES has completed the project to such a high standard.
