Christy Franco
Commercial & Manufacturing Strategy SME
Seminars
Thursday 26th March 2026
Roundtable Discussion: Process Economics in DNA Manufacturing: Clinical vs. Commercial Perspectives
9:40 am
- Distinguishing pre-clinical and clinical-stage manufacturing (“quick and dirty”) vs commercial production (cost-efficient, scalable, validated)
- Cost of goods analysis: when is cost reduction critical, and when can it be deprioritized?
- Impact of company size: regulatory trust in large pharma vs. hurdles faced by small biotechs
- Economic implications of synthetic DNA adoption for individualized vs. largepopulation therapies
Tuesday 24th March 2026
Building Quality Excellence in Nucleic Acid–Based Therapeutics: Harmonizing GMP Standards from DNA to Drug Product
1:00 pm
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.
