Building a LVV characterization and process validation strategy

Cell & Gene Therapy Insights 2019; 5(4), 511-515.


Published: 16 May 2019
Michael Burnham

Michael Burnham is the Director of the Vector Development department at Tmunity Therapeutics Inc. in Philadelphia. Mike has over 25 years’ of biosafety and bioprocessing expertise, and is currently working to establish Tmunity’s lentiviral vector manufacturing platform. Prior to joining the team, Mike worked at WuXi AppTec, serving in multiple roles in their Process Development, Viral Production/Purification and Viral Clearance departments. In these roles, Mike and his teams worked to develop new methods for virus purification and quantification, and to improve processes for the purification of client-specific biologics and gene therapy programs. Mike successfully developed novel purification strategies for multiple virus types to improve the growth, potency and quality of viruses used in Viral Clearance studies, as well as developing and validating assays for emerging viruses. He holds a BS in Biological Sciences from the University of Delaware and an MS in Biological Sciences from Rutgers University.