8:00 am | Registration & Morning Coffee

8:50 am Chair’s Opening Remarks

  • Bin Li Plasmid Production Leader, Sanofi

Unveiling the Current DNA Production Landscape & Innovative Platform Design to Advance Genetic Medicine

9:00 am The Genesis of Genetic Medicine: How We Got Here

Synopsis

  • Outlining how recombinant DNA technology is the forerunner to the age of biotherapeutic manufacturing
  • What’s in a name? Precursor, raw, auxiliary, starting material, or drug substance – classifying your DNA and its associated regulatory guidelines
  • Plasmid DNA or synthetic DNA – which route should you take and why?

9:30 am Unlock Next-Gen mRNA Therapy Development – Rapid, Cell-Free DNA Manufacturing

Synopsis

  • Cell-free DNA production offers a streamlined highly scalable workflow for mRNA therapy development
  • Elimination of cell-based cloning enables researchers to evaluate a more diverse sequence space faster
  • Bypassing pDNA with NGS-verified, complex, full-length linear IVT-ready DNA eliminates time and costs of establishing master cell banks

10:00 am Showcasing Roche’s Integrated Cutting-Edge Plasmid DNA Production Platform for Off-the-shelf Cell & Gene Therapies

Synopsis

  • State-of-the-art bioprocess development by applying the latest technologies
  • How to create a production platform that can produce plasmids for multiple modalities to reduce production time & costs
  • Scaling up production sustainably and in a cost-effective manner to produce large yields of plasmid DNA by an E2E single-use bioprocess

10:30 am | Morning Break & Speed Networking

Synopsis

Our dedicated speed networking session is the perfect opportunity to have in-depth conversations and forge long-lasting connections with fellow technical experts working with plasmid and synthetic DNA

Unleashing the Potential of Synthetic Methods for Faster Production of High Quality DNA

11:30 am Optimized Linear Synthetic DNA: Speeding up Delivery Times for High-Quality GMP Material with a Broadened Application Scope

Synopsis

  • Understanding how to reduce delivery times of GMP DNA template to 6-8 weeks instead of waiting 8 months for a pDNA template
  • Increasing mRNA production yield by three times with high purity
  • Reducing the mRNA cost by 40%

11:45 am Revolutionizing DNA Process Development: Showcasing a Cutting-Edge Platform for Cell-Free Production of Synthetic DNA

Synopsis

  • Sourcing high-quality raw materials and lowering cost of goods to kickstart synthetic DNA production
  • Controlling DNA production through enzymes delivered at precise concentrations and time points under optimal reaction conditions
  • Accelerating purification and isolation of plasmid DNA while ensuring minimal residual contamination to recover high-quality DNA

12:15 pm Reserved for Touchlight

12:30 pm | Lunch Break & Networking

Increasing Isolation: Maximizing Purification Efficiency for High Quality DNA Yield

1:30 pm Evaluation of Purification Modalities: Enhancing Process Robustness & Removal of Residuals

Synopsis

  • Development of a scalable plasmid purification platform 
  • Comparing purification modalities for efficient removal of impurities
  • Generation of impurities to leverage analytical methods and improve process

2:00 pm Roundtable Discussion: Boosting DNA Isolation: Mastering Precision Purification Techniques to Enrich Plasmid DNA for Various Modalities

Synopsis

  • How can we accelerate chromatography-based purification by determining the optimal conditions such as flow rate and column size?
  • How to optimize resin parameters like ligand selection and density to maximize the binding capacity of chromatography columns
  • How to efficiently removing contamination like RNA and genomic DNA to increase supercoiled DNA purity

2:30 pm | Poster Session & Afternoon Networking

From Precision Plasmid Design to Recovery: Elevating Expression Levels & Lysis Efficiency to Reduce Loss of DNA During Production

3:15 pm Enhancing Plasmid DNA Quality & Stability: Strategically Tailoring Plasmid Construct Design to Advance the Modality of Choice

  • Jing Liao Head of Vector Technology, Alexion Pharmaceuticals

Synopsis

  • Studying traditional plasmid backbones and specifically ITR regions to consistently produce high-quality plasmid
  • Correlating the plasmid design with the AAV vector genome packaging efficiency and manufacturability
  • Unveiling the impact of the plasmid design on the AAV quality and potency

3:45 pm Maximizing the Recovery of Plasmid DNA: Accelerating Workflow to Increase the Efficiency of Lysis & DNA Extraction

Synopsis

  • Developing efficient lysis procedures tailored to plasmid DNA extraction to reduce genomic DNA contamination
  • Controlling important parameters to reduce shearing stress on plasmid DNA and promote a high yield of unbroken plasmids
  • Closely monitoring parameters such as pH, buffer choice, and salt concentrations to prepare the extract for purification

4:15 pm Maximizing Quality of novel DNA vectors

Synopsis

  • Applications of linear covalently closed ministring DNA (msDNA)
  • The Sucrose Toxicity (SuTox) assay: A highly sensitive approach to measure the accuracy of DNA synthesis
  • High quality and enhanced fidelity of msDNA

4:45 pm Chair’s Closing Remarks

  • Bin Li Plasmid Production Leader, Sanofi

5:00 pm | Drinks Reception