Search, identification, and curation of cell and gene therapy product regulations using augmented intelligent systems.

Background: Manually keeping up-to-date with regulations such as directives, guidance, laws, and ordinances related to cell and gene therapy is a labor-intensive process. We used machine learning (ML) algorithms to create an augmented intelligent system to optimize systematic screening of global regulations to improve efficiency and reduce overall labor and missed regulations.

Methods: Combining Boolean logic and artificial intelligence (i.