Qualification of cellular starting materials for cell-based therapies

Cell & Gene Therapy Insights 2019; 5(2), 177-196


Published: 28 March 2019
Expert Insight
Elizabeth Read

Cellular starting material is unique because of the living, dynamic nature of cells that must be collected from a human donor. The process for donor screening and testing to reduce risk of infectious disease transmission is complex and not harmonized globally. Biologic, donor-to-donor variability is difficult to control and has major impacts on development of the manufacturing process and final product specifications. Maintaining stability of the material requires attention to the complex supply chain for a given manufacturing model. This article presents the key elements, regulatory expectations and special challenges for qualification of cellular starting material.