Manufacturing innovation
Our expert team will collaborate with you to accelerate your advanced therapy manufacturing and supply chain needs ensuring they are robust and efficient, whilst meeting all regulatory requirements. You can benefit from our Manufacturing Innovation Centres in Stevenage and Braintree located in the heart of a rapidly growing UK ATMP ecosystem. Accessing unique adaptive GMP cleanrooms designed to support the development and large-scale production of your autologous cell, allogenic cell, or viral vector manufacturing processes.
Our areas of expertise include:
Technology transfer and GMP manufacturing
Working in collaboration with you, our expert team will help adapt and transfer your processes for Good Manufacturing Practice (GMP) manufacturing.
Through our unique collaborative model, you can benefit from our state-of-the-art facilities in Stevenage and Braintree. Our 7,700m2 Stevenage Manufacturing Innovation Centre is MHRA licensed with 12 segregated GMP clean room modules and analytical laboratories. Braintree Manufacturing Innovation Centre is 4,600 m2 with additional process development laboratories. Our capabilities in technology transfer and GMP production enable you to rapidly set up and develop your ATMP manufacturing process whilst benefitting from our expertise and infrastructure, reducing your risk and time to market.
Benefit from our expertise in:
Manufacturing strategy
We have a team of specialists from across the ATMP lifecycle who help develop a robust manufacturing strategy.
Intellectual property (IP)
You can develop your process while retaining intellectual property; the people, process, quality management system, batch release, and IP all belong to the collaborator.
Technology transfer
Develop your process for scale-up and GMP production.
MHRA licensing
Ensuring you can produce material for clinical or commercial use.
Flexible, modular manufacturing
Our modular Manufacturing Innovation Centres enable you to adjust your manufacturing strategy as you grow from clinical to commercial manufacturing.
Digital and automation
Demand for cell and gene therapies is outpacing innovations in scalable manufacturing and supply chain technologies. Step changes in productivity are required to reduce costs and increase accessibility of advanced therapies to patients globally.
We are facilitating the development and implementation of innovative automation and digital technologies that are essential to increase manufacturing scalability, sustainability and cost-efficiency.
Benefit from our expertise in:
Digital and automation testbeds
A GMP-like environment for rapid testing and deployment of CGT manufacturing innovations for industrial scale-out and scale-up of CGT manufacturing.
Process control and monitoring
State-of-the-art process analytical technology (PAT) and biomarker discovery labs assessing rapid, high-throughput sample collection and analysis, and integration of PATs, advanced analytical tools and digital twins to enable improved process characterisation and control.
Digital connectivity
Integration of critical manufacturing systems into digital management platforms for seamless, secure and accurate data capture and transfer.
Chemistry, manufacturing & control (CMC)
Chemistry, manufacturing and control (CMC) compliance ensures consistent quality for production of ATMPs.
Developing a CMC regulatory strategy involves robust quality assurance and quality control to ensure that final product is safe and efficacious for use. We can support you with all these elements, ensuring your processes will deliver a product that complies with regulations and is ready to scale.
Benefit from our expertise in:
Quality control
Access the latest analytical procedures for ATMPs.
Quality assurance
Leading knowledge in the regulations for ATMP production.
Environmental monitoring
Maintaining the right environment for product production.
Supply chain
We have worked closely with industry and therapy developers to establish solutions that optimise the supply chain for manufacturing of ATMPs.
Benefit from an established ATMP manufacturing ecosystem in:
GMP storage
Local cryogenic storage facility at Stevenage through ThermoFisher's CryoHub.
Sterile kitting for GMP production
Maximise production efficiency through sterile kitting of GMP material and reagents.
Established UK supply chain
Benefit from the existing supply chain utilised by our Stevenage and Braintree Manufacturing Innovation Centres.
Working on a cell or gene therapy innovation challenge?
Contact us today to find out how we can support you.