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
11:50 am Simply scaling DNA from R&D to GMP with dbDNA™ (doggybone DNA) technology
Synopsis
In this session you will learn:
- How to eliminate historical plasmid transition barriers from R&D to GMP with cell-free DNA
- How the proven dbDNA cell-free DNA technology enables faster transitions to the clinic
- How to lower COGS through the use of dbDNA
12:00 pm Lunch & Networking
Defining Impurity Thresholds & Assessing Supplier Quality to Pave the Future of DNA Manufacturing
1:00 pm Quality Considerations for Evaluating & Assessing External Plasmid Suppliers & CMOs
Synopsis
- Setting quality expectations on plasmid quality with vendors to streamline external manufacturing efficiency and release
- Aligning vendor workflow and production quality with internal requirements to accelerate release of advanced therapies
- Evaluating vendor quality, making informed decisions on selecting vendors and harmonizing partnerships to maximize efficiency of pDNA production and quality
- Defining critical quality aspects when qualifying and onboarding new vendors
1:30 pm A Novel Membrane-Based Chromatography Platform for Enhanced Downstream Purification of Plasmid DNA
Synopsis
- A novel membrane-based chromatography platform for efficient plasmid DNA purification
- High binding capacity and recovery to overcome the challenges associated with large plasmid sizes
- Enhanced productivity through reduced cycle time and the reusability of the platform
1:40 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