Meet us at the International Oligonucleotide and Peptide Conference (IOPC) 2019
During IOPC 2019, connect with Intertek to explore how we can help you accelerate your oligonucleotide development programs.
Intertek is proud to sponsor the inaugural event, IOPC 2019, at the Ramada Plaza Milano, 17-18 September, 2019 focussing on topics at the forefront of oligo and peptide innovation, regulatory and market trends. Meet the team at Booth #16 or contact us now to arrange a meeting during the event. Our expert, Jo-Anne Riley, Senior Scientist with the Oligonucleotide Services Team will be presenting on the analytical considerations for the development of nucleic acid-based therapies.
IOPC 2019 PRESENTATION:
CMC Considerations for mRNA based Therapeutics
Tuesday, 17th September 2019, 10.40AM, Oligos Track
Jo-Anne Riley, Senior Scientist, Oligonucleotides Services Team
Messenger ribonucleic acid (mRNA) has the potential to treat a wide range of human diseases by exploiting natural in vivo protein synthesis machinery. With advancement of mRNA based therapeutics through clinical phases comes the requirement for mRNA characterisation and establishment of GMP validated analytical methods for quality control. Testing can include measuring the size or molecular weight of the mRNA, characterisation of the 5′ cap structure and poly (A) tail, as well as tests for impurities which can be directly linked to translation efficiency and immunogenicity. Analysis of the associated delivery systems, such as lipid nanoparticles, also forms a key part of mRNA drug product testing. This presentation will give an overview of the analytical considerations for mRNA therapeutics.
If you would like a copy of the presentation, please send a request now to receive the slides after the event.
Meet Our Expert:
Jo-Anne began her analytical chemistry career in 2007 with an undergraduate placement in the Structural and Separation Science team at Pfizer. This was followed by a Chemistry PhD at the University of Southampton focussed on mass spectrometry of oligonucleotides. Jo-Anne has five years’ experience working to cGMP standards performing analytical method development and validation and routine analysis for batch release and stability studies using a range of analytical techniques. This academic background in therapeutic oligonucleotides combined with industrial experience of GMP analysis led to Jo-Anne joining Intertek’s Oligonucleotide Services team in April 2018.
- 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 Characterisation of Oligonucleotide Therapeutics
- 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.