As nucleic acid–based therapeutics advance from research to commercialization, ensuring quality consistency and GMP compliance across the entire product lifecycle has become a defining challenge. Participants will gain actionable strategies to strengthen quality oversight, enhance inspection readiness, and de-risk production from plasmid DNA to final drug product through proactive, integrated GxP approaches.

This workshop will address:

• Implementing risk-based Quality Management Systems (QMS) that ensure DNA integrity, traceability, and process control across both plasmid and synthetic DNA platforms
• Addressing persistent alignment challenges between interstitial standards, risk assessments, and evaluations
• Managing variability in pDNA material quality, testing methods, and evaluationcriteria, and identifying approaches to harmonize standards across the industry
• Determining which analyses are essential versus optional for Certificates of Analysis (CoAs) to balance compliance requirements with operational cost efficiency.