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| This Advancing RNA discussion will be a deep dive into the world of plasmid sourcing and quality considerations. What quality attributes matter the most for producing the desired quality of mRNA? What are the current gaps in our knowledge of plasmid quality, and how are we as an industry striving to close these gaps? Register today and find out. |
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By Anna Rose Welch, Advancing RNA | Though our guidances have helped us achieve upwards of 20 commercially approved oligo products, as I listened to GSK’s director of CMC policy and advocacy, Katie Duncan, present at TIDES, it struck me just how far we have yet to come. Here, I single out a few of the biggest topics of regulatory discussion shaping the oligo therapeutics market. | |
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Reassessing Nanoparticle Immunotoxicity Approaches New And Old | By Marina A. Dobrovolskaia, Frederick National Laboratory for Cancer Research | This article highlights government-funded resources available to de-risk nanomedicines, reviews principles of immunotoxicity testing, and discusses emerging methodologies. |
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| Defining LNP Formulation Parameters For Scale-Up Success | White Paper | By Mahesh Karwa, Ph.D., Teresa Demuth, Ph.D., et al., MilliporeSigma | Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing. |
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| The Bioanalysis Report You Actually Get Back Fast | Article | Dash Bio | Manual assay variability compromises regulatory filings. Discover how automated workflows replace human error with repeatable processes to boost data precision and audit readiness . |
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| The Economic Case For Continuous Manufacturing | Article | By Aaron B. Cowley, Ph.D., Recipharm Advanced Bio | Traditional batch production drags down therapeutic margins. Explore how continuous manufacturing platform models utilize real-time analytics to slash timelines, costs, and risks . |
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| Webinar: Autonomous Impinging Jet Mixing for LNP Process Development | Lipid nanoparticle (LNP) development can be slow and resource-intensive. Discover how impinging jet mixing, automation, inline analytics, and data-driven optimization can accelerate process development and enable more predictive manufacturing. This Knauer webinar will explore closed-loop experimentation, automated design of experiments, self-optimization, and modeling approaches that can help identify robust conditions faster and support scalable, reproducible LNP production. Click here to learn more. |
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