Pre-Conference Focus Day: Plasmid DNA Manufacturing
Tuesday, September 26, 2023
7:30 am Registration & Morning Coffee
8:20 am Chair’s Opening Remarks
Optimizing Plasmid DNA Manufacturing Controls from Fermentation to Purification to Ensure Cost-Effectiveness & Scalability
8:30 am Defining USP Standards for Plasmid DNA as a Starting Material for Cell & Gene Therapy
Synopsis
- Reporting an overview of the USP general chapter process
- Describing key quality attributes recommended for plasmids
- Harnessing best practices for the manufacturing of plasmids and master cell banks
9:00 am Enhancing Plasmid DNA Manufacturing Process Development for mRNA Applications
Synopsis
- Advancing fermentation process development
- Clarifying purification process development
- Trailblazing process analytics
9:30 am Evolving Strategies for Plasmid Purification
Synopsis
- Exploring different chromatographic options for the purification of supercoiled plasmid and the linearized plasmid template
- Evaluating linearization at different levels of plasmid purity
- Determining the impact of linearized plasmid purity on product quality
10:00 am Morning Break & Networking
Harnessing Cell-Free Synthesis for the Future of Plasmid DNA Manufacturing
10:30 am DNA Templates for mRNA Synthesis
Synopsis
- Showcasing methods for production of linear DNA
- Harmonizing regulatory considerations
- Improving codon optimization
11:00 am Optimized Linear Synthetic DNA as GMP Starting Material to Improve mRNA Production & Delivery Times
Synopsis
- Improving IVT yield to lower the cost per dosage
- Developing more accurate and optimized linear DNA templates much faster for advanced therapies
- Delivering safer starting materials containing only the sequence of interest without any bacterial DNA
11:30 am Round Table Discussion: Cell-Free vs Traditional Plasmid DNA Production – Establishing the Future of Plasmid Manufacturing to Reduce Costs & Maintain Quality
Synopsis
- How to establish the best DNA production method to producing step free, large quantities of DNA for multiple transcription reactions
- How to use the enzymatic method vs high scale, plasmid DNA manufacturing method to eliminate costs and reduce time
- Discussing the advantages and disadvantages of cell-free synthesis to combat bottlenecks in plasmid DNA production
12:30 pm Lunch Break & Networking
Optimizing Plasmid DNA Production Methods to Improve Speed & Effectiveness for Next Phase mRNA Production
1:30 pm Reviving of a Legacy DNA Vaccine E. coli Plasmid Fermentation Process by Utilizing Single-Use Technology to Support a Modern mRNA Vaccine Program
Synopsis
- Adapting a legacy DNA vaccine that used stainless-steel reactors to develop a novel mRNA vaccine that uses single-use fermenters
- Overcoming a variety of roadblocks to success including pDNA construct stability, chemical compatibility with single-use fermenter materials, and capability limitations of the existing bioreactors
- Leveraging thoughtful development and knowledge-sharing to produce sufficient supply of pDNA in AMBR250 and BioBlu 3f SUF bioreactors to fuel IVT development activities
2:00 pm Process & Analytical Control of mRNA Poly A Tails: Challenges & Lessons Learned
2:20 pm Round Table Discussion: Combating the Poly-A Tail Challenge From Plasmid DNA to mRNA Production
Synopsis
- How to effectively sequence and measure poly A tails from DNA design to mRNA
- How to overcome specificity challenges with longer Poly A sequences to ensure translational efficiency
3:20 pm Chair’s Closing Remarks
3:30 pm End of Pre-Conference Focus Day
4:00 pm Private Hosted Site Tour by Curia
Synopsis
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