RNA Analytical/Quality Videos

  1. The Challenges Novel Lipids Pose For mRNA-LNP Manufacturing 2/24/2026

    Though there are a lot of exciting advancements being made with novel lipid chemistries, CMC Consultant Sujit Jain provides an important reality check for us: These innovations break established platforms, requiring fresh process development, complex impurity profiling, and new vendor qualifications.

  2. Are We Missing mRNA Drug Substance CQAs? 6/9/2026

    As a field, we’ve been aligned around CQAs for our mRNA drug substances. However, differences in translation between highly similar mRNAs (i.e., (same sequence, same design, different manufacturers) raises the question of whether we’re missing any QAs/CQAs. Here, Advancing RNA Live panelists Elaine Peters and Ilya Shestolapov share their take. 

  3. In Which Specific Areas Do mRNA Makers Need More Regulatory Guidance? 5/10/2024

    Experts from this Advancing RNA Live panel discuss the results from a poll question revealing the top three areas RNA industry experts would be most interested in seeing additional mRNA-specific guidance from regulatory agencies.

  4. The Current State of CDMO Platforms For gRNA Production 4/29/2026

    Max De Long, April Sena, and Venkat Krishnamurthy share their perspectives on the current “health” of CDMO SPOS and enzymatic ligation platforms, while also highlighting the “red flags” to look out for when taking stock of a CDMOs capabilities. 

  5. Goldilocks & The Guidances: Finding "Just Right" For RNA Regulations 6/24/2025

    Do we need more specific regulatory guidance for every RNA modality and therapeutic approach? We asked and the Advancing RNA Live audience answered… Here, panelists Tiffany Lucas and Ulrike Jägle address the audience’s responses, as well as share their thoughts on just how prescriptive the future of regulatory guidance for RNA therapeutics approaches could/should be..

  6. Why Current dsRNA Analytics Don't Quite Cut It 10/15/2025

    In this Advancing RNA Live segment, several speakers raise concerns about the industry's ability to accurately measure impurities, particularly dsRNA, arguing that current analytics are insufficient, especially for high-dose therapeutics.

  7. Taming dsRNA Via Innovation In The Supply Chain 10/15/2025

    Here, Ethris’ Christan Dohmen and Tune Therapeutics’ Stu Sundseth share their take on the most meaningful strategies for reducing dsRNA production. But this discussion also probes a deeper question: Is dsRNA still the most relevant impurity the industry should be chasing, or should focus shift to other contaminants? 

  8. The Strategic Shift(s) In gRNA CMC 4/29/2026

    In this opening Advancing RNA Live clip, panelists Max De Long, April Sena, and Venkat Krishnamurthy share the biggest scientific and manufacturing breakthrough made in the world of gRNA production over the past year. 

  9. mRNA/saRNA Manufacturing: Accelerate The Path To Clinic 3/22/2021

    Discover key upstream and downstream considerations for process development for RNA drug substance manufacturing and the parameters that need construct-specific optimization to increase yield and reduce impurities.

  10. Beyond Purity: Addressing the FDA's CMC Expectations for gRNA 4/29/2026

    Advancing RNA Live panelists Venkat Krishnamurthy, April Sena, and Max De Long share their perspectives on the most important regulatory considerations for gRNA production utilizing an enzymatic ligation approach.