Process Development, Scale-up And Challenges Of Adenovirus GMP Process In The iCELLis™ Bioreactor

By Pirjo Merilahti, Petri Rummukainen, Marie-Laure Collignon, and Clement Pebre

Scalable production of adenovirus vectors using adherent cell systems presents significant technical and operational challenges, particularly during GMP scale-up. A structured development strategy is outlined, beginning with bench-scale optimization and progressing to large-scale manufacturing while maintaining critical quality attributes. Process performance is driven by data-led optimization of infection parameters, perfusion control using metabolic indicators, and refined lysis conditions to maximize infectious yield. Practical scale-up hurdles—including complex seed trains, large-volume buffer handling, and transition to closed workflows—are addressed through careful planning and engineering alignment. Comparative results across scales demonstrate consistent cell growth, metabolic behavior, and virus productivity, reinforcing process robustness. The approach highlights how disciplined experimentation, scalable design principles, and proactive risk mitigation enable reliable translation from development to manufacturing.

These insights support teams advancing adherent cell–based viral vector processes toward late-stage development and commercial readiness.