Flow virometry for process monitoring of live virus vaccines-lessons learned from ERVEBO.

摘要: Direct at line monitoring of live virus particles in commercial manufacturing vaccines is challenging due to their small size. Detection malformed or damaged virions with reduced potency rate-limited by release assays long turnaround times. Thus, preempting batch failures caused out specification results almost impossible. Much needed are in-process tools that can monitor and detect compromised viral live-virus (LVVs) based on changes biophysical properties provide timely measures rectify process stresses leading such damage. Using ERVEBO, MSD's Ebola vaccine as an example, here we describe a flow virometry assay quickly mechanistic insight into parameters contributing the Furthermore, 24-h high throughput infectivity be used correlate directly loss (potency) in-process. Collectively, set innovative enable rapid development, monitoring, control strategy implementation large scale LVV manufacturing.