Cancer Research UK – Biotherapeutics Development Unit

Having outgrown their existing BDU Facility in South Mimms, Hertfordshire, which was coming to the end of its lifespan, CRUK required a new state of the art facility to undertake the discovery, production and pre-clinical trials of novel anti-cancer agents.

The 2000 sq.m facility was required to be designed and constructed to exceed GMP requirements and provide flexible accommodation to meet future needs.

Accommodation was required for GMP production, GMP support, final fill process, assay development and QC laboratories.

Austin provided a full design, manage and construct solution including DQ, IQ and OQ validations of the facility and services. It was designed and constructed to exceed UK Building Regulation L2 requirements and was demonstrated to achieve an exceptional air leakage test rate of 3.3 m3/hr/m2 versus an industry norm. of 10.0 m3/hr/m2 at 50pa.

Highly serviced contained clean areas to Class 10,000 (ISO 7/Grade C) and Class 100,000 (ISO 8/Grade D) were provided with low level extract, fully cascaded, to ensure containment and continually monitored by a validated environmental monitoring system.

The design provided enhanced details to exceed cGMP such as flush dado trunking to maximise working space and allow deep cleaning and recessed stainless steel utilities ports for easy connection to services.

Other features include self-supporting walk-on ceilings for easy access to HEPAs, lighting fixtures and controls; vaporised hydrogen peroxide fumigation system; stand by generation; inverter drives to HVAC plant for energy conservation and integration of autoclaves, ovens, glasswashers and safety cabinets/LAF.

The unit was delivered on time with savings to the Client in excess of £1m. The success of Austin working closely with the client resulted in Austin being awarded the Best Supplier Award from Cancer Research UK.