Hear from our experts during TIDES Oligonucleotide & Peptide Therapeutics Digital Week
Learn more about our oligonucleotide analytical development services at TIDES: Oligonucleotide & Peptide Therapeutics Digital Week, 16-19 September 2019.
During TIDES: Oligonucleotide & Peptide Therapeutics 2019 Digital Week, Intertek will present an overview on nucleic acid based therapies and analytical considerations to accelerate product development from early characterisation to late-stage development and commercialisation.
CMC Considerations for Nucleic Acid Based Therapeutics; from Antisense to mRNA
Monday , September 16, 2019, 9AM EST, 2PM BST
Thomas Brown, Senior Analyst Oligonucleotide Services, Intertek Pharmaceutical Services
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.
If you would like a copy of the presentation, please send a request now to receive the slides after the event.
Visit the TIDES Digital Week website to learn more and register for sessions.
Meet Our Expert:
Tom is a senior analyst within the Oligonucleotide team at Intertek. He has worked on analysing oligonucleotides by NMR to GMP standards and also has prior experience with small molecule NMR within the pharmaceutical industry. He regularly presents at conferences and authors papers on the topic of oligonucleotide characterisation by NMR
Case Study: Identification Testing by Accurate Mass and MS/MS Sequencing
Case Study: Oligonucleotide Identification, Assay and Impurities
Case Study: Determination of Melting Temperature for Oligonucleotide Duplexes using NMR
Article Download: Analytical challenges in the oligonucleotide characterisation
White Paper: Analytical Strategies for Quality Control of Oligonucleotide Therapeutics
With a growing global development pipeline of oligonucleotide therapeutics to treat a variety of disease targets, overcoming the challenges of innovation, regulatory authorization, production and the inherent complexity of oligos is critical to success. Contact our experts in oligonucleotide analysis and bioanalysis, to discuss our regulatory-driven, phase-appropriate characterization and biophysical analysis in support of CMC programs which GMP and CMC laboratory services, pharmaceutical analysis, quality control analysis, elemental impurities, extractables and leachables, stability programs, inhalation drug development, method development and method validation will be available to review your challenges and discuss and how our unrivalled expertise can help you to accelerate the development timelines.
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