Explore the Agenda
8:00 am Check-In, Coffee & Light Breakfast
Workshop A
9:00 am Optimizing Upstream & Downstream Workflows for High-Yield Plasmid DNA: From Research-Grade Development to Industrial GMP Production
DNA serves as a foundational component across multiple therapeutic modalities, from templates for mRNA and viral vectors to raw materials for cell and gene therapies. Designing DNA with downstream processing in mind is critical to ensure scalability, product quality, and regulatory compliance. This workshop will explore key design and process considerations that influence DNA manufacturability, purity, and functional performance. Participants will examine how DNA sequence design, synthesis methods, and process architecture affect subsequent purification and formulation steps across different therapeutic platforms.
Join this workshop to:
- Explore design factors (vector architecture, sequence composition, size, and topology) that DNA processability and downstream behavior
- Select the right capture method: comparing resin based, HIC and affinity techniques across modalities
- Evaluate the interplay between DNA quality attributes (supercoiling, residuals, impurities) and product performance in various modalities
- Discuss emerging technologies for scalable DNA manufacturing, from enzymatic synthesis to continuous downstream platforms
12:00 pm Morning Break & Refreshments
Workshop B
1:00 pm Building Quality Excellence in Nucleic Acid–Based Therapeutics: Harmonizing GMP Standards from DNA to Drug Product
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.