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CMC Considerations for Nucleic Acid Based Therapeutics; From Antisense to mRNA
9am EDT / 2pm BST / 3pm CEST
The scope of nucleic acid based therapeutics covers a vast array of types of molecule, ranging in size from approximately 20 nucleotides for antisense oligonucleotides to thousands of nucleotides for mRNA based drug products. Similar analytical techniques can be applied to each type of molecule, for example chromatographic analysis for impurities, but the approach to method design will take into consideration the different types of impurities associated with each type of molecule. Analysis of the associated delivery systems, such as lipid nanoparticles, also forms a key part of drug product testing. This presentation will give an overview and comparison of the analytical considerations for a range of nucleic acid based therapeutics.