U.K.-based Cell and Gene Therapy Catapult (CGT Catapult) opened a new laboratory in Stevenage which has been specifically designed and equipped to allow cell and gene therapy developers to monitor and control their advanced therapy manufacturing processes in real-time. The goal is to improve product quality and safety while increasing production levels.
The Process Analytical Technologies (PAT) lab was designed to provide an analytically and digitally enabled space for cell and gene therapy developers to ensure the quality of their products is controlled and retained as they prepare to scale up production. Maintaining product quality and process efficiency is fundamental to scaleup and bringing a therapy to large numbers of patients, explains Matthew Durdy, chief executive of CGT Catapult, adding that the process information and control that the facility provides will enable will be valuable to discussions with regulators.
In-line and on-line monitoring equipment
Collaborators in the laboratory will be able to use in-line and at-line monitoring equipment, together with a multi-omics approach to identify and assess critical process parameters in real-time, while automation and digitalization will facilitate rapid control of their process, continues Durdy.
Moving from producing a small quantity of a cell or gene therapy to producing a larger quantity is often challenging. These products derive from complex biological materials, which are sensitive to environmental changes. The environmental change associated with scaleup in production presents a significant manufacturing challenge to developers.
The PAT laboratory will be located near to current collaborators and developers working at the CGT Catapult Manufacturing Innovation Centre, as well as other developers in the area.
The opening of the laboratory follows the conclusion of the PAT consortium, a group of twenty-four organizations 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.
“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,” notes Durdy. “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.”