8:00 am | Morning Networking & Coffee

8:50 am Chair’s Opening Remarks

Illuminating Regulatory Pathways for Plasmid DNA Production Through Perspectives from the Industry

9:00 am Quality Considerations of Plasmid DNA as a Starting Material for Cell and Gene Therapies

Synopsis

  • Present an overview of the USP general chapter <1040> and the process for creating the chapter
  • Describe the requirements for key quality attributes recommended for plasmids 
  • Discuss the best practices for the manufacturing of plasmids following feedback from the industry

9:30 am Mastermind Discussion: Addressing Burning Questions, Concerns, & Providing Clarity with Current Regulatory Guidelines for the Production of DNA as a Starting or Therapeutic Material

Synopsis

This unique session provides attendees with the chance to come together and discuss their greatest challenges and questions, and gain regulatory guidance on DNA production, both plasmid and cell-free. It is also your opportunity to ask questions and provide feedback on the regulatory guidelines discussed today.

10:30 am | Morning Break & Networking

Amplifying Therapeutic Impact: Customizing DNA Production Strategies for Advanced mRNA Synthesis

11:30 am Tackling Challenges in Plasmid DNA Production for Efficient mRNA Synthesis

Synopsis

  • Addressing the bottleneck of slower pDNA production to align with the faster mRNA synthesis process
  • Overcoming technical hurdles in designing a rapid and efficient platform for pDNA production
  • Developing a versatile platform capable of consistently producing new plasmids with high efficiency

12:00 pm From Gene to LNP: Nucleic Acid Research and Proprietary Manufacturing Technologies of Wacker Biotech

  • Mack Kuo Associate Director of Process Development, Wacker Biotech US Inc

Synopsis

  • Innovative pDNA technologies
  • State-of-the-art mRNA manufacturing and LNP formulation
  • R&D to GMP Supply at Wacker Biotech

12:10 pm DNA Matrices for mRNA Synthesis

Synopsis

  • Production of linear DNA for mRNA synthesis
  • Regulatory considerations when producing linearized plasmid DNA for mRNA applications
  • Codon optimization during plasmid design for optimal production of DNA

12:40 pm | Lunch Break & Networking

Supercharging Plasmid DNA Analytics: Integrating Next-Gen Sequencing, Developing Robust Assays & Creating a Framework for Plasmid Classification

1:40 pm Roundtable Discussion: Optimizing Analytical Development to Create a Toolkit for De-Risking Critical Stages in Plasmid DNA Production

Synopsis

  • How to develop fit-for-use analytics to enable comprehensive plasmid characterization and assessing suitability for downstream therapeutic applications
  • How to implement a targeted testing approach to minimize redundancy and streamline the plasmid development process by focusing on critical checkpoints
  • How can we tailor analytical testing to enable consistent quality for both off-the-shelf and personalized plasmids?

2:40 pm Decoding DNA Sequencing: Evaluating Sanger Versus Next-Generation Options for Plasmid DNA Analytics

Synopsis

  • Comparing options such as Sanger sequencing versus next-generation sequencing for accurate sequence analytics
  • Balancing between long-read sequencing’s insights into complex genomic regions and short-read sequencing’s high-throughput coverage to ensure holistic plasmid analysis
  • Enabling enhanced depth Sanger sequencing to facilitate accurate analysis of sequence conservation through production

3:10 pm Plasmid Classification & Associated Framework for Development of Science & Risk Based Approach

  • Basak Clements Global Head of Materials Sciences Cell & Gene Therapy, Genentech

Synopsis

  • Plasmid classification and review of regulatory framework
  • Application of science and risk-based approach to define plasmid controls
  • Considerations for external and internal manufacturing of plasmids through a science and risk-based approach

3:40 pm Chair’s Closing Remarks

4:00 pm | End of DNA Process Development & Manufacturing Summit