White Paper
Abstract
Advanced therapeutics such as stem cell and gene therapies are expensive whether an autologous or allogeneic product is used for patients. There is an imperative to comply with good anufacturing practice for generation of approved products as well as extensive pre-clinical and clinical testing to validate the effectiveness of advanced therapy medicinal products (ATMPs) before use on patients. Minimising costs during the manufacturing process, without a loss of rigour, is a necessary step to enable expansion of the gene and stem cell fields for patient benefit. Manual production incurs significant costs associated.
