Track Title: Oligonucleotide Chemistry, Manufacturing & Controls (CMC)
Navigating the Complexities of Oligonucleotide Development from Lab to Market
Dive deep into the critical CMC aspects of oligonucleotide therapeutics development. This track addresses regulatory strategies, innovative manufacturing technologies, analytical method validation, and quality control challenges essential for bringing RNA-based medicines to patients.
About This Track
Dive deep into the critical CMC aspects of oligonucleotide therapeutics development. This track addresses regulatory strategies, innovative manufacturing technologies, analytical method validation, and quality control challenges essential for bringing RNA-based medicines to patients.
The critical role of CMC in successful oligonucleotide therapeutic development and regulatory approval
The evolving regulatory landscape and global harmonization efforts for synthetic oligonucleotides
Key challenges: manufacturing scalability, impurity control, analytical characterization, stereochemistry control, and sustainability
The track's focus on emerging technologies, green chemistry initiatives, and innovative analytical approaches that are transforming oligonucleotide production
Solving Critical CMC Challenges
Challenge 1: Regulatory Complexity
Navigate evolving global CMC guidance with direct insights from regulatory authorities
Challenge 2: Manufacturing Scalability
Learn about emerging technologies that enable cost-effective, large-scale production
Challenge 3: Impurity Control
Implement comprehensive analytical and purification strategies for product quality
Challenge 4: Sustainability
Adopt green chemistry principles to reduce environmental impact while maintaining quality
Track Focus Areas
Regulatory CMC Strategies
Navigate the complex global regulatory landscape for oligonucleotide therapeutics with insights from industry leaders and regulatory authorities.
Sessions:
Regulatory CMC Strategies for Oligonucleotides
Shifting Landscape: Global Regulatory CMC Guidance for Synthetic Oligonucleotides
Regulatory CMC Strategies and Health Authority Interactions for Oligonucleotide Programs
Regulatory Landscape for Synthetic Peptides and Oligonucleotides: EMA Insights and Guideline Updates
Finding the Right Balance: How Formulation Aspects and Regulatory Expectations Affect Steam Sterilization of Antisense Oligonucleotide (ASO) Drug Products
Emerging Manufacturing Technologies
Explore cutting-edge manufacturing approaches that are revolutionizing oligonucleotide production, from enzymatic methods to advanced synthesis platforms.
Sessions:
Emerging Technologies in Oligonucleotide Manufacturing
Enzymatic Ligation for the Production of Oligonucleotides
Stirring Things Up: Integrating Stirred-Bed SPOS and Enzymatic Ligation for Industrial Oligonucleotide Production
Advancing siRNA Manufacturing with User-defined Phosphorothioate Stereochemistry
Hybrid Enzymatic vs. Chemical Ligation
Analytical Method Validation Across the Oligonucleotide Lifecycle
Process Innovation & Sustainability
Learn about innovative strategies for impurity control, process optimization, and sustainable manufacturing practices in oligonucleotide production.
Sessions:
Innovations in Oligonucleotide CMC
Strategies for Implementing a Comprehensive Impurity Control Approach Across Oligonucleotide Purification Process
Moving Towards a Greener SPOS Process
Rethinking Green Credentials for Oligo Manufacturing
Part 1: siRELIS: A Convergent Enzymatic Ligation Strategy for siRNA Manufacturing; Part 2: Enzyme Development for Oligonucleotide Therapeutics Manufacturing
Analytical Methods & Quality Control
Discover advanced analytical techniques and quality control strategies for comprehensive characterization of oligonucleotide therapeutics and mRNA products.
Sessions:
Delivery, Analytical and CMC Strategies for Oligonucleotides and mRNA
Neutral Backbones and Dendrons for Enhanced Therapeutic Oligonucleotides Delivery
The Bayer LNP Platform for the Delivery of Therapeutic RNAs
Maintaining Diastereomeric Control in Phosphorothioate siRNAs: Integrated Analytical and Manufacturing Approaches for Reliable Clinical Development
Addressing Challenges in the Development and Quality Control of Individualized mRNA Products
Synthesis and Characterization of Stereopure Chimeric Oligonucleotides
LC-MS Innovation for Impurity Profiling of Oligonucleotide Therapeutics: Ion-Pair Hydrophilic Interaction Chromatography (HILIC) and FOCUS Two-Dimensional LC (2DLC) MS Methods
Who Will Benefit from This Track?
- CMC and regulatory affairs professionals
- Process development and manufacturing engineers
- Analytical development scientists
- Quality control and quality assurance managers
- Formulation scientists
- Purification and downstream processing specialists
- Supply chain and tech transfer professionals
- Pharmaceutical development executives
- Contract manufacturing organization (CMO/CDMO) representatives
- Academic researchers transitioning to industry