RNA Analytical/Quality Videos
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Decoding Regulatory Expectations: The Art Of A Successful IND Submission
6/24/2025
Companies often underestimate the information required for IND submissions, particularly in a sector that’s as diverse as the mRNA sector. Here, former FDA reviewer Tiffany Lucas shares some of the missteps companies can make when first approaching the FDA with their IND. CureVac’s Ulrike Jägle furthers the discussion, offering a critical best practice she and her colleagues rely upon as well to streamline their regulatory interactions.
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Bioinformatics In mRNA Development: Classification And Integration Conundrums
6/24/2025
As both Advancing RNA Live speakers point out in this segment, the MHRA guidance focuses deeply on the critical role bioinformatics and AI/ML approaches will play in the development of personalized immunotherapies. Here, Eliquent Life Sciences’ Tiffany Lucas and CureVac’s Ulrike Jägle address the biggest challenges they anticipate companies will face in meeting the agencies’ recommendations.
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Fermentation, Analytics, & Quality: Plasmid Production Advancements & Challenges for mRNA Development
4/11/2025
Advancing RNA Live panelists Tyler Goodwin and April Sena start off our latest discussion on technology innovations in mRNA production by surveying the current manufacturing process for plasmid production, highlighting where they’ve seen advancements and what biotechs need to consider to obtain plasmids of the appropriate quality for mRNA production.
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Strategies To De-Risk Next-Gen mRNA Raw Materials
12/3/2025
In this Advancing RNA Live clip, Khaled Yamout and Sanofi’s Francoise Ribes share the quality considerations that are top of mind when evaluating a novel raw material, as well as how the broader industry (i.e., standard setting organizations, suppliers, and biotechs) can arrive at a clearer understanding of a material’s quality.
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Don't Forget These Important Points When Selecting An RNA CDMO
8/22/2024
Together, Omega’s Jeff Atkinson & Sail Biomedicines’ Jim Nolan share their perspectives on the health of the linear mRNA and circRNA outsourcing sector.
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Closing the Gap: How NIST is Addressing gRNA Quality
4/29/2026
Life Edit Therapeutics’ April Sena provides an update on NIST’s gene editing consortium, teasing forthcoming deliverables from a working group focused on gRNA quality.
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Analytical Limitations In Assessing Plasmid Quality for mRNA Production
4/11/2025
There remain a lot of gaps in our understanding of plasmid quality, particularly for high-quality mRNA production (as opposed to viral vector production). In this segment of a recent Advancing RNA Live panel, speakers Adi Nair, Tyler Goodwin, and April Sena highlight their biggest questions around plasmid DNA quality, as well as the pros and cons of some of the analytical methods upon which we’re relying most heavily today to assess plasmid quality.
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Crafting A "Durable" Partnership: A Two-Pronged Approach
Featured speakers for the "Got Raw Materials? The State Of The mRNA Supply Chain" event share how they are working to deepen their partnerships today.
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What Learnings Can mRNA Take From The Oligonucleotide Regulatory Paradigm?
5/10/2024
ReciBioPharm’s Melanie Cerullo shares where mRNA needs to “catch up” to its oligonucleotide “cousin” molecules and where regulatory differences may be emerging between modalities.
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Where Does The mRNA Vaccine Regulatory Paradigm Fall Short For Therapeutics?
5/10/2024
This Advancing RNA panel of experts sees a couple of important questions those striving to make RNA therapeutics will find themselves confronting when collaborating with regulators.