The Challenge
Following a rapid rise of advanced therapy trials in the UK, in 2018 the Cell and Gene Therapy Catapult (CGT Catapult) identified that a continued lack of available GMP manufacturing capacity was a key barrier faced by therapy developers when trying to progress their ATMPs towards the clinic. To ensure the UK had the right manufacturing innovation capacity and capability in place to support the growing industry, CGT Catapult set out to expand its existing manufacturing facility to meet this need.
CGT Catapult secured funding to double the capacity of its Stevenage Manufacturing Innovation Centre (Stevenage MIC) from six cleanroom modules to 12. To effectively support the sector, this expansion needed to be delivered at speed to satisfy the expanding number of therapy developers requiring capacity. CGT Catapult sought the support of an appropriate construction company to collaborate with, to build the highly specialised and flexible facility expansion.
The Collaboration
Merit, a North-East based industrialised construction and digital manufacturing company delivering advanced therapy biomanufacturing facilities, had a forward-thinking approach to construction involving off-site, modular manufacturing. Utilising advanced 4D BIM modelling technology and a product-based approach, Merit designs and delivers high-quality, technically complex facilities in a third of the time compared to traditional methods of construction. With CGT Catapult collaborating with Merit as the contractor to fit out this expansion, the teams worked together around the design and construction of the facility with an aim to deliver the expansion space and in a validated state at speed, and to leverage the existing operational systems within the Stevenage MIC to allow additional collaborators to set up quickly.
With Merit’s expertise in off-site construction and CGT Catapult’s real-world experience of cell and gene therapy manufacturing cleanroom design and validation, the expansion was delivered in half the time compared to traditional methods of construction, 40 weeks, and with minimal disruption to existing collaborators already operating to GMP within the Stevenage MIC.
Through this collaboration, CGT Catapult presented Merit with a unique opportunity to refine its novel approach and verify that it had the speed and flexibility required to deliver GMP facilities in the advanced therapies sector. The collaboration provided Merit with additional learnings for modular building and further demonstrates that its experience is applicable to GMP environments that require a Medicines and Healthcare Regulatory Agency (MHRA) inspection and approval. Subsequently Merit established a new capability around pre-assembled modules suitable for advanced therapy manufacturing facilities – providing an innovative approach to construction, combining off-site manufacturing to produce GMP approved facilities, where commissioning and validation could be achieved in just eight days.
Where are they now?
Since Merit’s technology and qualification model was proven in the Stevenage MIC, Merit has continued to evolve and demonstrate its offsite, volumetric design principles and ability to deliver robust facilities at pace and scale in many cell and gene therapy manufacturing and healthcare sites in the UK, delivering on sustainability goals such as zero Scope 1 carbon and EPCA ratings.
These include Autolus Therapeutics’ cell therapy facility in Stevenage, constructed in around a third of the time that would be required using traditional construction methods, and an mRNA vaccine manufacturing facility for CPI in Darlington, which was established in just 32 weeks. In addition, Merit’s capabilities are now attracting GMP manufacturing companies to the UK, with Moderna’s decision influenced by Merit’s proven capability to accelerate its plans at the Harwell Campus, Oxfordshire. This increase in demand for Merit’s offering, developed from the learnings gained and capability developed from working with CGT Catapult, has led to a significant expansion of their operations based in the North-East, increasing employment in the region.
Merit has experienced exponential growth since the project with CGT Catapult, having over doubled its workforce between 2021-2023 to over 300 staff, whilst also expanding its offsite manufacturing facility in 2023 with a 44,000sqft factory expansion to create over 50 more jobs. The expansion also enhances Merit’s ability to deliver over £0.5 billion of large capital projects across a variety of sectors including healthcare, biotech, pharmaceutical, expanding to £1.5 billion by mid-2024. Merit’s offsite manufacturing facility is one of Europe’s largest off-site manufacturing facilities at 263,000sqft and is testament to the attractiveness of the organisation.