The production of novel antibody-drug conjugates at ADC Biotechnology’s North Wales, United Kingdom, manufacturing plant has been boosted with the completion of a new cleanroom facility.
The development of antibody-drug conjugates involves highly potent cytotoxic drugs. This presents a safety challenge for those engaged in early development and clinical product manufacturing and bio conjugation processes.
The cleanroom was designed and built by engineering company WHP and forms a key part of ADC Bio’s construction of a new bioconjugation facility at the company’s site in Deeside, North Wales, United Kingdom for the commercial production of antibody-drug conjugates in response to a growing global customer demand.
According to market estimates calculating growth for ADCs until 2030, the global market for antibody-drug conjugates is expected to grow at a compound annual growth rate of 19.4%. The focus is on ADCs being manufactured with novel conjugation approaches and agents with more potent payloads and modified linker technologies.
Antibody-drug conjugates are a class of emerging biotherapeutics that require a tailor-made and customized infrastructure to ensure strict compliance with the highest global regulatory standards.
Antibody-drug Conjugates used in human clinical trials (Phase I – III) must be manufactured in an aseptic biological environment operating under cGMP. Such an aseptic environment should be designed to isolate manufacturing personnel from exposure to highly cytotoxic chemicals, including the ADCs payload, but, in addition, also prevent microbial contamination of the process intermediates and drug final product during the conjugation process. To accomplish this, a such a facility needs to meet both cGMP and safety requirements and requires specific engineering and design.
WHP is a multi-disciplinary engineering company which was awarded the UK £ 5 million (US $ 6.22 million) contract in December 2017.
The new facility – which includes support areas for washing, depyrogenation, thawing and buffer preparation – sees drug manufacturing in a stringently controlled environment, operated under cGMP regulations. This eliminates any risks during antibody modification and conjugation that could support the development of environmentally-borne microbial contaminants.
Scope of work
WHP’s scope of work covered the design and build, including test and validation of a state-of-the-art containment manufacturing cleanroom within an existing 6,500 sq/m (70,000 sq/ft) high tech facility, along with new quality control and process development laboratories.
Auto-cad design work encompassed cleanroom architecture, M&E components and process and critical utilities systems. Also featuring complex zoned HVAC systems to maintain segregation, cleanliness, air pressures, and other environmental controls, the cleanroom facilities have been developed in compliance with regulations from the Medicines and Healthcare products Regulatory Agency (MHRA), an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
Low toxic waste system
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 off-site incinerator. This system incorporates dry break couplers to seal off both ends of the pipeline to prevent the possibility of any onsite contamination.
“We are building a best in class facility to the highest possible global standards. 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,” said Charlie Johnson, Chief Executive Office at ADC Bio, an innovative biotechnology company developing new process technology to speed, simplify and significantly lower the production costs of the latest generation of antibody-drug conjugates.
“It’s a facility we are extremely proud of that will help our customers develop vital new medicines for patients globally,” he added.
“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,” noted WHP’s project manager, Chris Douglas.
“This latest project reflects growing success in delivering high quality cleanroom technologies across the pharmaceutical sector, providing customers with expertise, knowledge and one-stop-shop solutions,” Douglas concluded.