Risk assessment of plasmid complexation to support robust GMP-compliant implementation of an rAAV manufacturing platform for gene therapy

Puntos clave

• The aim is to evaluate the risk of plasmid complexation to enhance the manufacturing of rAAV gene therapy while complying with GMP standards.
• Risk assessment methodology applied to plasmid complexation and rAAV manufacturing processes.
• Study conducted in compliance with GMP regulations.
• Analysis structured to support robust production frameworks.
• Identified key risk factors associated with plasmid complexation during rAAV production.
• Demonstrated improved predictability in manufacturing outcomes under GMP compliance.
• Provided a framework for evaluating plasmid interactions in gene therapy context.