Pre-Conference Workshop Day
7:50 am Check In & Light Breakfast
8:50 am Chair’s Opening Remarks
Enhancing DNA Fidelity & Quality by Measuring Impurities to Increase Yield of High-Value DNA for Potent Therapies
9:00 am Impacts of Plasmid Product Quality Attributes on mRNA PolyA Tail Length
Synopsis
- Understand the importance of pDNA as a starting material on mRNA product quality to inform plasmid design
- Navigating DNA polyA tail length heterogeneity to guide upstream process development decisions
- Engineering a plasmid that impacts polyA tail length to maximize product quality
9:30 am Optimizing Plasmid DNA Clarification to Maximize DNA Purity
Synopsis
- Evaluating different parameters to minimize key DNA impurities: host cell DNA and open circular DNA
- Exploring alternative clarification unit operations to enhance impurity removal and increasing yield
- Understanding key scaling parameters during lysis and clarification operations
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
Refining Upstream Process Development & Fermentation to Maximize Downstream Recovery & DNA Stability for Higher Efficiency Advanced Therapeutics
11:30 am Optimizing Fermentation Conditions for Robust Plasmid Production
Synopsis
- Reducing fermentation stresses for robustness of plasmid production
- Balancing growth and yield for plasmid production to maximize efficiency
- Evaluating media conditions for optimal growth and plasmid recovery
12:00 pm Tailor Made Synthetic DNA: Shortening Delivery Time, High Quality Material & Improving its Performance According to Application
Synopsis
- Delivery time, from milligrams to grams scale: 2 weeks
- High Quality GMP Material
- Optimized synthetic DNA, maximizing its functional performance according to applications and client requirements
12:15 pm Debottlenecking Vaccine Manufacturing; Simplifying DSP Process
Synopsis
- Optimizing host strain, plasmid design, media composition and fermentation conditions for high biomass, plasmid yield and quality, facilitating downstream purification of ScpDNA
- pDNA recovery is a critical step in the downstream process, removing most contaminants while concentrating pDNA
- Pharmaceutical pDNA has stringent requirements of purity, homogeneity, and efficacy, and SC pDNA is the most stable, efficient, and biologically active
12:45 pm Lunch & Networking
Elevating Effective Lysis & Purification of DNA to Increase Downstream Efficiency & Yield to Maximize Manufacturing Efficiency
1:45 pm Thinking Beyond Traditional Resin Based Chromatography for Improved Purification & DNA Quality
Synopsis
- Exploring the possibilities of monolithic resins, membrane absorbers and ion exchange chromatography to effectively purify pDNA
- How to maintain cost-effectiveness whilst employing advanced purification methods to ensure sustainable DNA production
2:15 pm Session Reserved for BIA Separations
2:45 pm Panel Discussion: Optimizing Downstream DNA Process Development through Novel Lysis & Purification Methods to Protect Yield & Quality
Synopsis
- How to streamline downstream process development and employ the latest methods and technologies to maximize efficiency of DNA production
- How to reduce the manufacturing timeline and maintain cost efficiency whilst producing high quality starting materials and API
- Understanding the regulatory landscape of lysis and purification of DNA for use in advanced therapies
3:30 pm Afternoon Break & Poster Session
Synopsis
This is your opportunity to share your innovations and breakthroughs with your DNA manufacturing peers
Integrating Analytical Testing & Quality Control Methods to Streamline Release of Manufactured DNA for High Quality mRNA, Cell & Gene Therapies & Vaccines
4:30 pm Analytical Considerations for Plasmid DNAs as Starting Material for Cell & Gene Therapy Products in Clinical Development
Synopsis
- Outlining the characterization and quality control of plasmid DNAs
- Employing HPLC, UV and NGS tools to test quality attributes to understand pDNA purity
- Stability behaviour and shelf-life setting for long-term storage to maximize use of pDNA and advanced therapies
5:00 pm Accelerating & De-risking the Path to Clinical Drug Development with the Cell-Free Synthesis of DNA
Synopsis
- Unlock greater speed and sequence diversity for screening by eliminating the time spent cloning plasmid DNA
- More economically scale DNA synthesis for personalized therapy
- De-risk clinical scale-up earlier in the development process
5:30 pm Ministring DNA: a Novel Linear DNA Minivector with Superior Fidelity & Enhanced Stability for Gene Therapy Applications
Synopsis
- Enhancing stability of gene therapies with Ministring DNA through resisting destabilization, maintaining structural integrity at critical pH levels, and ensuring consistent non-viral gene delivery
- How Trehalose-enabled lyophilization allows for room-temperature storage while maintaining functionality, facilitating use in low-resource settings
- Ensuring high fidelity, scalability and regulatory compliance through in vivo manufacturing in E.coli