RNA Analytical/Quality Videos
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The Evolving CMC Landscape For mRNA-LNPs
2/24/2026
In this Advancing RNA Live clip, CMC consultant Sujit Jain unpacks the levels of maturity he’s observed in process and analytical development, as well as supply chain. While vaccines and liver-targeting therapeutics boast what we can call a reproducible platform today, targeted LNP therapies introduce a handful of scale-up sensitivities and characterization hurdles.
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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.
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Must-Have CDMO Capabilities And MSA Make-Or-Breaks For mRNA-LNP Outsourcing
2/10/2025
Three Advancing RNA Live panelists share their greatest needs in outsourcing partnerships for mRNA/RNA-LNP products and where sponsors should be the most prescriptive when drafting an MSA with an outsourcing partner.
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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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Sustainable Vaccine Manufacturing: Securing The Future Of Global Health
7/22/2025
Explore how next-gen technologies, from mRNA platforms to digital tools, are transforming vaccine manufacturing to make it more sustainable, flexible, and accessible.
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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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A&M STABTEST Shares QC Analysis Of Oligo Therapeutics
9/20/2022
Explore best practices for developing a QC method for identification and impurity analysis of oligonucleotides, as well as tips on mitigating risk by using compliant instrumentation and software.
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How Is mRNA "Shaking Up" Our Regulatory Interactions & Operations Today?
5/10/2024
The Advancing RNA Live panelists share several inconsistencies they’ve encountered working with global regulators, as well as on which aspects they’re seeing regulatory agencies applying greater scrutiny in mRNA development today.
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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.
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The Latest And Greatest Technological Innovations In mRNA-LNP Production
2/10/2025
In this segment, Replicate Biosciences’ Andy Geall, Qian Ruan, & Alex Aust identify the most promising technological and raw material innovations that are influencing the drug substance and drug product production processes at CDMOs.