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About Us - Global Project Delivery Specialists | PM Group
Cell and Gene Therapy Catapult
Cell and Gene Therapy Catapult manufacturing centre
Location
United Kingdom
Key Statistics
- Client
- Cell and Gene Therapy Catapult
- Year
- 2018
- PM Group Office
- Birmingham
- Cost
- £75m
- Size
- 7,700 sq.m.
The Cell and Gene Therapy Catapult is at the centre of the rapidly growing global cell and gene therapy industry in the UK. The facility is now home to several innovative companies. Each of them is developing their own GMP manufacturing process and working towards clinical trial or full commercial supply. Having provided the concept design and engineering consultancy services during the design phase of this unique development, PM Group continued to support the facility through onsite technical support, via our Outsourced Technical Services model.
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Andy Rayner
Pharmaceutical Sector Director
ATMP product development
The primary driver for the project was to deliver a GMP compliant space for different cell therapy companies to develop ATMP products. The design concept helped establish the framework for a design around the potential volumes, materials and the number of collaborating companies the facility might serve.
PM Group’s scope was to develop a Concept Design, delivering on the novel idea and unique requirements of the Cell and Gene Therapy Catapult. This scope was delivered in 2014 and in 2018 the facility successfully opened, staying true to the original concept developed by PM Group.
A World First
The facility design is a world first and without cGMP precedent. It allows organisations to manage their manufacturing operations with high levels of confidentiality. Challenges were overcome to facilitate identical cleanroom suites or ‘Modules’ in close proximity to each other. Segregation was required not only for regulatory compliance, but also for individual confidentiality of individual companies. This meant working closely with the Medicines and Healthcare products Regulatory Agency (MHRA) early in the facility design.
Flexible, adaptable facilities
The initial requirement was to establish the metrics of a basic manufacturing module, segregated from any other suites to provide separate access, egress, services and environments.
This was established from analysing the spatial requirements of the potential manufacturing equipment, potential staffing numbers and the associated ergonomics. Furthermore, each module would need to be both flexible and adaptable without compromising the activities of any other module.
12 production modules form the basis of space available for collaborators. All other building facilities such as warehousing, QC, welfare and administration are common and maintained by CGT Catapult.
Continuing relationship
As a unique facility, with a unique operating model, a novel approach was required to gain MHRA manufacturing licence approval. PM Group provided continued consultancy and engineering support to write SOP’s and develop procedures and ways of working. The culmination of this work was CGT Catapult being granted licence approval in August 2018.
PM Group continued to support CGT Catapult through our Outsourced Technical Services model.