Viral Vector Commercial Process Characterization and Validation

We apply our deep process characterization experience and DoE methodology to define the CPPs and CQAs that enable robust processes, optimal yields, and effective control strategies. Our approach and available services:

• Review existing process history and data
• Conduct preliminary risk assessment
• Define/Characterize the unit operations, the KPPs and CPPs, that impact CQAs
• Design and conduct DoE studies
• Generate tabular data and reports to support regulatory filings
• Multiple 2L and iCELLis® NANO bioreactors and ambr® 15 for DoE studies
• Media testing and validation
• Resin reuse studies
• Viral inactivation and clearance validation