Bioprocess monitoring and control: challenges in cell and gene therapy. (December 2021) - Emerson, Joe
Abstract : Bioprocess monitoring and control are an essential requirement for safe and effective manufacture of bioproducts. This review provides an overview of some of the latest developments in analytical techniques, process variability, monitoring and control approaches for biologics, with a specific emphasis on the growing sector of cell and gene therapy. The monitoring and control challenges arising from the broad range of cell and gene therapy products, the complexity of these products and the processes required to produce them are outlined. Perspectives and implementation challenges are then set in the context of the regulatory framework.