Merit

Autolus Therapeutics

The UK’s first CAR-T cell manufacturing facility.

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Do you need a bioscience facility built fast?

Discover how Merit’s expert team delivered phase one Grade C Cleanrooms for UK’s first CAR-T cell manufacturing facility for Autolus Therapeutics in record time; only 17 months, with just 12 months spent on site. This included concept design and planning, to commissioning and validation.

Having originally intended to build the facility in America, Autolus instead chose to build in the UK, due to Merit’s fast-track offsite manufacturing approach which could deliver on time and to budget.

Delivering 3 years faster than the industry standard means that Autolus Therapeutics can produce 6000 life-saving cancer treatments by 2025.

 

  • Includes Grade C cleanrooms, laboratories, offices and warehouse accommodation.
  • The Merit design layout maximised manufacturing space by positioning plant on the rooftop and utilising distribution PAMs.
  • BREEAM Excellent and zero carbon emissions design.

The Autolus project is the first UK CAR-T cell manufacturing facility and will be the first Autolus manufacturing facility in the world. Autolus Therapeutics is a clinical-stage biopharmaceutical company developing next-generation programmed T-Cell therapies that will expand its current capabilities into a new 7,500m2 facility in Stevenage. The new facility will enable development of CAR-T cell therapies for cancer treatment, enabling the re-programming of patients’ immune systems so they can more easily recognise cancer cells.

Merit had to design the facility to be MHRA/FDA complaint and be into early offsite manufacturing after only 3 months in parallel with the planning application. At that time there was not even a concept design in place before Merit’s appointment.

The team utilised their offsite manufacturing capabilities, delivered using its FLEXI POD® platform and Pre-Assembled Modules (PAM) standard platform approach, which facilitates the fast-track project timelines. 300 PAMs and 15 UltraPODs® have been manufactured at our factories in Northumberland and shipped to site for installation by our specialist in-house installers.

The use of digital design and digital 4D and 5D BIM modelling has been successfully demonstrated by Merit on the Autolus project. By using such technologies, Merit was able to fast-track the programme and digitally engineer the building and construction sequence before the PODs and PAMs arrive on site.

Critical to the compressed programme was to fix the 1:200 layout design. The layout was constrained by the tight site, planning requirements in terms of height to fit process equipment adjacently and the MHRA/FDA requirements for people, product and waste flows.

Autolus was the first project that Merit developed a digital twin for. The twin was developed in Revit and was designed to capture all the detail from the fixtures and fittings to the pipework and equipment of the mechanical and process pipework systems. The development of the twin allowed Merit to accurately assess the time taken to install onto the PODs and PAMs and to then attach an itemized cost onto each individual item. This information is used in the development of the platform design to build a ‘what it should cost’ model.