3rd Oligonucleotides CMC and Analytical Development Summit

The 3rd Oligonucleotides CMC and Analytical Development Summit covers topics such as:

• Regulatory Guidance for a New Era of Oligonucleotide Development
• Outlining Current Industry Trends in Oligonucleotide Development
• The Use of Risk Assessment to Evaluate the Quality Impact of Raw & Starting Materials Used in mRNA Manufacturing
• Debating Analytical Methods & Validity for Alternate Oligonucleotide Types
• Advancing Oligo-Conjugates Through Analytical Development
• Ensuring Sequence Specificity as ASO Production Increases
• Upstream Innovation: Analytical Development of Oligonucleotides to Enhance Processes
• Strategies for Enhancing Oligonucleotide Drug Formulation With Patient Adherence in Mind
• Application of NMR for PMO Characterization & Process Control Strategy
• Delving Into Downstream AD & CMC Toolboxes
• Development of AEX & HILIC as Orthogonal Separation Methods to IPRP for the Characterization of Purity & Impurities in Oligonucleotide Products to Ensure Quality
• Development & Application of 2D HPLC for PMO Analysis & Impurity Profiling
• Bridging the AD Gap to Simplify Development
• Balancing Resolution & Equipment Complexity to Streamline Transfer to CMC Teams
• Analytical Comparability for Tech Transfer & Process Change
• Ensuring Reliable Product Quality to Facilitate Market Success
• Process Development & Scale-up of GalNAc-Conjugated siRNA
• Manufacturing Process Development for 2’-O-N-methylacetamide Oligonucleotides
• Scalability & Process Economics Considerations for Oligonucleotides to Reach Additional Patient Groups
• Back-Tracking Oligonucleotides for Process Validation & Improving Process Economics
• Safe-Guarding Process Efficiency & Yield to Improve Cost
• Looking Long-Term: Sustainability Strategies in Oligonucleotide Manufacturing to Minimize Environmental Impact
• Implementing Ultrafiltration/Diafiltration for Processing ASOs to Improve Efficiency
• Synthesis of RNA Fragments on a Soluble Support