Conference Day Two | Thursday, March 27, 2025
7:50 am Check In & Light Breakfast
8:50 am Chair’s Opening Remarks
Investigating Cell-Free DNA Production as an Alternative to Plasmid Production to Facilitate Informed Process Development Decisions to Maximize Quality & Efficiency
9:00 am Deep-Dive Workshop: A Side-by-Side Comparison of Cell-Free DNA & pDNA: Comprehending the Cost, Quality, Usability, & Timeline of Synthetic DNA
Synopsis
Ideally, DNA manufacturing should be affordable, flexible, responsive to demand and producible at scale. Cell-free DNA synthesis promises all of this and more – but what is the reality of using synthetic DNA? Share your experience of cell-free DNA and hear from
experts who have turned to cell-free manufacturing when traditional methods prove limited.
This workshop will address:
- Considering advantages, breakthroughs and challenges of cell-free DNA
- Reviewing the side-by-side comparisons of cost, speed, fidelity, immunogenicity, accuracy and quality when using cell-free and plasmid DNA
- Exploring challenges in navigating the regulatory landscape of cell-free DNA and how to overcome these hurdles to enter the clinic
- Assessing the limitations and exploring the potential of cell-free DNA for the future of advanced therapeutics
12:00 pm Lunch & Networking
Defining Impurity Thresholds & Assessing Supplier Quality to Pave the Future of DNA Manufacturing
1:30 pm Round Table Discussion: How Pure Should DNA Be? Understanding Purity Thresholds for DNA as a Starting Material or API through Analytical Tests
Synopsis
- Understanding the significance of DNA purity as a drug substance or starting material
- Selecting appropriate bioanalytical and quality control tests to accurately measure impurities
- How to safeguard against mutations, unwanted isoforms and variable expression to create DNA with high yield and fidelity
2:30 pm Afternoon Break & Networking
Successfully Navigating Regulatory Guidance for pDNA Production to Facilitate the Release of Vaccines & Cell & Gene Therapies to Meet Increasing Demand
3:00 pm Plasmid DNA Strategy as a Starting Material for mRNA Pharmaceuticals
Synopsis
- Evolution of industry understanding of regulatory expectation
- Understanding phase appropriateness of manufactured DNA
- Unravelling the ongoing global strategy discussion
3:30 pm Comprehending Regulatory Guidelines for pDNA Manufacturing to Increase the Chance of IND Approval
Synopsis
- How to understand phase appropriateness and ascertain when GMP should be applied to processes and materials
- How to comprehend acceptable thresholds of DNA isoforms, genomic DNA and impurities
- How to maintain appropriate documentation throughout production to support IND submissions