Scope and challenges of managing particulates in cell therapy manufacturingPublished: April 10, 2017
Raw Materials for Cell & Gene Therapy: Getting it Right from the Start
Dr Jean Stanton
Dr Jean Stanton joined Johnson and Johnson (J&J) in 2008 after more than 20 years in the healthcare industry, developing cell-based therapies. Jean is responsible for leading the integration of cell and gene therapy regulations into Janssen’s internal quality standards. Jean works closely with the business and development organization, establishing compliance strategies relating to cell and gene therapy products as well as supporting due diligence activities, regulatory agency interactions and health authority inspections. Jean’s current responsibilities also include the deployment and maintenance of the R&D compliance program for all GMP aspects within the J&J Pharmaceutical sector, which includes the development and maintenance of the quality and compliance strategies to support all novel products that are in-licensed or developed within Janssen.DOI: 10.18609/cgti.2017.023
Citation: Cell Gene Therapy Insights 2017; 3(3), 165-169.