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
