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

ABSTRACT: Direct at line monitoring of live virus particles in commercial manufacturing of vaccines is challenging due to their small size. Detection of malformed or damaged virions with reduced potency is rate-limited by release potency assays with long turnaround times. Thus, preempting batch failures caused by out of specification potency results is almost impossible. Much needed are in-process tools that can monitor and detect compromised viral particles in live-virus vaccines (LVVs) manufacturing based on changes in their biophysical properties to provide timely measures to rectify process stresses leading to such damage. Using ERVEBO, MSD's Ebola virus vaccine as an example, here we describe a flow virometry assay that can quickly detect damaged virus particles and provide mechanistic insight

SUBMITTER: Ricci G 

PROVIDER: S-EPMC8016999 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature