Senior Director, Global Head Technical and Scientific Solutions at Merck KGaA
Dr. Alison Armstrong is Senior Director , Global Head of the Technical and Scientific Solutions team. Dr Armstrong has a long history in academic research as a postdoctoral scientist and Research fellow and has been involved in examining the role of viruses in various pathogenic conditions. She has led a number of teams in different divisions within Merck; operational teams, validation and scientific development, and she is currently responsible for a scientific consultancy team with the remit to support clients in technical, scientific, and regulatory issues. During her career Alison has authored many different articles on trends in biosafety testing and is a member of regulatory taskforce groups related to microbiology and virology methods and alternate and rapid technologies. She is an invited speaker at international conferences. Dr. Armstrong holds a PhD in Molecular Virology from the University of Glasgow
Thu. February 23 | 3pm – CMC considerations for Cell and Gene therapy products
Ensuring the safety and quality of cell and gene based therapeutic products is achieved through a multi-tiered approach that examines several factors to establish product safety and manufacturing consistency.
Over the past years there has been a dramatic increase in the number of clinical trials involving cellular based therapies. The nature of these novel therapeutic strategies presents testing challenges when compared to traditional therapies that may include limited shelf life and limited testing sample size as well as a need for reduced turnaround times. As a consequence, existing testing approaches are often not suitable for these products.
We provide an analysis of the current state of the testing regimes undertaken to ensure product quality. Testing strategies for raw materials, production intermediates and final product are outlined and novel technology including cell characterization, identity and stability, microbial testing and detection of adventitious viruses are reported. The implementation and validation of rapid assay methods and suitability of new testing platforms that allow for streamlining testing and reporting are also discussed and case studies presented.