Uncertainty and innovation: Understanding the role of cell-based manufacturing facilities in shaping regulatory and commercialization environments

This study aims to fill an empirical gap in the literature that explores how CPT manufacturing facilities navigate current regulatory and commercialization environments in Canada, which together drive the translation of novel CPTs from bench to bedside. Using the multi-level model of practice-driven institutional change proposed by Smets et al., we demonstrate how CPT manufacturing practices are governed by established standards, yet meaningfully shape higher-order regulatory and commercial norms in CPT research and development.
Source: Applied and Translational Genomics - Category: Genetics & Stem Cells Source Type: research