PAT Laboratory offers Real-time Control of Manufacturing Processes

A new Process Analytical Technologies (PAT) Laboratory at the Cell and Gene Therapy Catapult (CGT Catapult) in Stevenage has been specifically designed and equipped for monitoring and controlling advanced therapy manufacturing processes in real-time, enabling cell and gene therapy developers to ensure the quality and safety of their products during preparation for scale up.

Therapies derived from complex biological materials present significant manufacturing challenges as they are sensitive to environmental change, thus maintaining control of process efficiency is fundamental to larger scale operations.

Collaborators in the laboratory will have access to in-line and at-line monitoring equipment, together with a multi-omics approach to identify and assess critical process parameters in real-time. The automation and digitalisation facilitating rapid control of their process will provide valuable information for discussion with regulators.

The PAT laboratory will be located near to current collaborators and users working at the CGT Catapult Manufacturing Innovation Centre, as well as other developers in the area. 

The laboratory’s initiation follows the conclusion of the PAT consortium, a group of 24 organisations comprising pharmaceutical companies, technology providers, therapy developers and charities brought together by the CGT Catapult in 2021 to better understand advanced therapy bioprocesses and analytical technologies.

Matthew Durdy, Chief Executive of the Cell and Gene Therapy Catapult said: “We are aiming to remove another barrier to the growth of the industry by enabling developers to transition from producing small amounts of a product for development, to producing much larger quantities to ultimately meet the needs of patients. This new facility provides a dedicated space for developers to identify the critical quality control points of their manufacturing process and use them to control their manufacturing process at scale, facilitating increased production levels and reducing costs.”

An independent innovation and technology organisation, the CGT Catapult is committed to advancing cell and gene therapies with potential for delivery of life changing treatments to the world. Working with Innovate UK, its aim is to create powerful collaborations which overcome challenges to the advancement of the sector.

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