(42an) Moving Towards a Sterile Chromatography Platform for Virus Purification

Process development of live virus vaccines presents many unique challenges owing to their size, molecular complexity, and structural heterogeneity. For downstream purification, one of the main challenges is the inability to sterile filter the virus at the end of the process.  Because of this limitation, all components of the purification process have to be sterilized and all operations must be performed under aseptic conditions.  This need for sterile operation limits the purification techniques that can be used to purify a virus.  While many biologics use chromatography as the work horse of the purification process, these chromatography steps are usually not operated aseptically.  Membrane chromatography offers one route to sterile operation; however, the number of functional chemistries are limited.  Therefore, this work examines the potential for sterile operation of conventional particle-based chromatography for live-virus vaccine purification by comparing batch and column modes as well as the impact of autoclave and gamma sterilization processes on resin functionality.