The role of canadian cell manufacturing facilities in shaping the regulatory and commercialization environments

Abstract

Translating the investments and knowledge obtained to date into products and therapies of tomorrow has become a major priority in the regenerative medicine (RM) field. Still, creating an environment propitious for clinical translation remains challenging. Across jurisdictions, the translational process is characterized by scientific, technical, regulatory and commercialization challenges. However, the relationship between these factors and innovation is not well understood. How do practices, networking activities and standardization efforts among different stakeholders enable or hinder innovation? To provide a better understanding of these issues, we conducted an exploratory multiple case-study of six GMP/cell manufacturing facilities in Canada. Our unit of analysis is comprised of staff’s experiences manufacturing or commercializing cell-based products and therapies intended for human use, and of personnel at the respective technology transfer offices. In addition, we interviewed staff at Health Canada to gather their experiences and views about the regulatory process.