The GMP facility in North Wales features Grade C and D cleanrooms and four-zone HVAC systems
Production of new anti-cancer drugs at ADC Bio’s North Wales manufacturing plant has been boosted following completion of a new cleanroom facility. The project has been designed and built by WHP.
The new GMP cleanroom is part of ADC Bio’s construction of a bioconjugation facility at its site in Deeside, North Wales (UK) for the commercial production of antibody-drug conjugates in response to global customer demand.
“We are building a best-in-class facility to the highest possible global standards," said Charlie Johnson, CEO at ADC Bio. "We awarded the contract to WHP on the back of its relevant industry experience and reputation for delivering cost-effective, single-source cleanroom design and build packages," he added.
Antibody-drug conjugates are a class of emerging biotherapeutics that require a bespoke infrastructure to ensure strict compliance with the highest global regulatory standards.
The biotech company awarded the £5 million contract to WHP in December 2017. The new facility sees drug manufacturing in a stringently controlled environment. The site is operated under cGMP regulations, and also comprises support areas for washing, depyrogenation, thawing and buffer preparation.
WHP’s scope of work covered the design and build, including test and validation of a state-of-the-art containment manufacturing cleanroom within the existing 6,500 sqm hi-tech facility, along with new quality control and process development laboratories.
The infrastructure includes a Grade C cleanroom on a 110 sqm area and a Grade D cleanroom on a 390 sqm area. The site also features four complex zone HVAC systems.
“The new cleanroom meets ADC Bio’s need to expand operations at Deeside beyond R&D to include safe, secure and highly efficient manufacturing capabilities," commented WHP’s project manager, Chris Douglas.
For Douglas, this latest project reflects WHP's "growing success in delivering high-quality cleanroom technologies across the pharmaceutical sector, providing customers with expertise, knowledge and one-stop-shop solutions".
A key feature of the project has been the installation of a bespoke low maintenance toxic waste system
WHP pointed out that auto-cad design work encompassed cleanroom architecture, M&E components and process and critical utility systems, and that the cleanroom facilities have been developed in compliance with MHRA regulations.
A key feature of the project has been the installation of a bespoke low maintenance toxic waste system, developed by WHP to remove cleanroom waste to a holding tank, where it is transported to an offsite incinerator.
This system incorporates dry-break couplers to seal off both ends of the pipeline to prevent the possibility of any onsite contamination.
“It’s a facility we are extremely proud of that will help our customers develop vital new medicines for patients globally," Johnson concluded.