The Cell and Gene Therapy Catapult (CGT Catapult) has opened a new laboratory in Stevenage, UK, which has been specifically designed and equipped to allow cell and gene therapy (CGT) developers to monitor and control their advanced therapy manufacturing processes in real-time, to improve product quality and safety while increasing production levels.
The new process analytical technologies (PAT) laboratory will provide an analytically and digitally enabled space for CGT 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 scale up and bringing a therapy to large numbers of patients. The process information and control that the facility will enable will be valuable to discussions with regulators.
Lab facilities and location
Collaborators in the laboratory will be able to use innovative 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 digitalisation will facilitate rapid control of their process.
Moving from producing a small quantity of a CGT 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 scale up in production presents a significant manufacturing challenge to developers.
The opening of the laboratory 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.”