Quality By Design in Plasmid DNA And Gene Therapy: ProBio CDMO's Digital QMS For Risk-Based Manufacturing Excellence

By Julie Erwin, Ph.D.; Ben Chen; Sham Lasker; Taruj Patel

Quality is the cornerstone of successful biomanufacturing, and achieving it requires more than compliance—it demands a culture of proactive improvement and collaboration. A risk-based approach to problem-solving ensures that deviations are assessed, investigated, and resolved according to their impact, reducing recurrence and safeguarding product integrity. This framework integrates structured workflows for root cause analysis and corrective actions, supported by digital tools that streamline documentation and quality management processes.

Central to this strategy is Quality by Design, which embeds quality principles throughout development and manufacturing. Electronic systems for document control, training, and risk management enhance transparency and traceability, while deviation management programs provide structured oversight from initial assessment to CAPA implementation. These measures not only meet regulatory expectations but also foster operational efficiency and client confidence.

Find out how a comprehensive quality roadmap—combining robust systems, digital platforms, and collaborative practices—can elevate standards and ensure consistent delivery of safe, high-quality products in the evolving landscape of cell and gene therapy.