Delivering a world class cell and gene therapy facility
The new state-of-the-art GMP manufacturing facility and training laboratory at RoslinCT’s BioCube building on Edinburgh’s BioQuarter, was delivered in partnership with Connect 2 Cleanrooms (C2C), in partnership with RoslinCT.
The BioCube is designed for clinical and commercially approved cell and gene therapy products and significantly increases its capacity to deliver life-changing therapies for customers and patients.
RoslinCT, a cell therapy Contract Development and Manufacturing Organisation (CDMO), work on developing cell and gene therapy research into robust GMP-qualified processes, enabling its clients to bring therapies safely to the patient.
GMP (Good Manufacturing Practice) is a system designed to ensure pharmaceutical products are created according to the highest quality standards. The new 1600m² GMP cell and gene therapy manufacturing facility will be used to develop life-changing, next-generation treatments for patients throughout the world.
As a cleanroom design and build specialist, C2C was appointed as Principal Contractor by RoslinCT at the end of 2019 with work commencing on-site in early 2020. In addition to the facility build, C2C provided an end-to-end service with an integrated supply of consumables, equipment, and validation.
The existing 2-storey BioCube building housed office and laboratory spaces. RoslinCT’s first stage expansion plan suggested alterations and fit-outs to create a modern 33-room manufacturing facility, with five cleanrooms at its heart. The planning and installation process was fully project managed by Connect 2 Cleanrooms at every stage—from the initial CAD drawings to completion.
C2C’s cleanroom design achieves space efficiency by using the latest decentralised air-handling technology. C2C created a Computational Fluid Dynamic study to plot airflow throughout the building and used 3D point cloud surveys to plan HVAC ducting, gas lines, interlocks, and raceways. Through this innovative planning of services, office premises were retained in the new facility for RoslinCT.
The decentralised air handling design not only saves space but also enables RoslinCT to perform maintenance in individual rooms without requiring full facility closure. Along with 24/7 controlled systems and a permanent generator, this allows flexibility and continuity for RoslinCT’s innovative cell and gene therapy offering.
Other noteworthy features of the cleanroom complex at RoslinCT include Vapourised Hydrogen Peroxide (VHP) hatches—for the full kill of microorganisms during materials transfer— and a 21 CFR 11 Environmental Monitoring System that continuously audits the environment to prove GMP-compliancy.
GMP guidelines were followed during the construction of the new facility to endure all relevant validation and commissioning protocols met regulatory requirements. The facility operates to US and EU GMP standards and ensures the highest standards for the end product.