RNA Analytical/Quality Articles
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Pictures At An [mRNA]Exhibition: What We Can Learn From Picasso (Pt. 1)
6/20/2025
In my presentation, I argued that there are three lessons we can learn from Picasso that will also help our own industry mature. In the upcoming weeks, I plan to unpack these lessons, highlighting specific instances in which I see our industry taking these lessons to heart and making progress — starting here with lesson 1: Being Innovative Comes After We Master The Basics
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Engineering The Next Generation Of Lipid Nanoparticles For Advanced Therapeutics
6/10/2025
Lipid nanoparticles (LNPs) face significant hurdles in clinical use due to challenges with their stability, manufacturing, and understanding how their complex characteristics impact therapeutic efficacy and safety.
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A Guide To Designing mRNA Medicines
6/10/2025
A poorly designed mRNA sequence can create ongoing difficulties during downstream clinical development and manufacture. Let's take a closer look at strategies and design software that you can employ.
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Designing Our Way Toward Circular RNA Medicines With AI
5/21/2025
The closed-loop structure of circular RNA can offer sustained, durable expression. We caught up with Sail Biomedicines' Kerry Benenato and Rajesh Ramaswamy to chat about ways to leverage AI for design/engineering.
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A Road Map For PAT Monitoring And Control
5/8/2025
Process analytic technology monitoring and control is rapidly progressing. BioPhorum shares new best practices on how to move from concept through life cycle management and/or regulatory approval of the PAT application.
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EMA Issues Draft Guideline On Quality Aspects Of mRNA Vaccines
5/6/2025
The EMA's new draft guideline applies to mRNA vaccines for infectious diseases, providing guidance on manufacturing, characterization, specifications, and more. The deadline for public comments is Sept. 30, 2025.
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Do We Really Understand Plasmid Quality's Effects On mRNA Production?
5/1/2025
Two experts examine the current guidelines and specs for plasmid DNA and question whether our understanding is sufficient.
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ICH Revises Q1 Guideline, Advancing Stability Testing Standards
4/24/2025
In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.
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"Mirror, Mirror…": Reflections On Reducing mRNA Production COGS
4/21/2025
Here, I outline three overarching words of wisdom I gleaned from Life Edit Therapeutics’ April Sena; Tune Therapeutics’ Tyler Goodwin; and University of Sheffield’s Adi on how the mRNA/RNA industry can better control production costs — particularly as it relates to raw material sourcing and usage.
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Plasmid Production: 3 Key Takeaways For mRNA Manufacturing
4/14/2025
Following my latest Live panel on analytical and manufacturing technology innovations for mRNA production, I wanted to provide a few high-level takeaways I gleaned from our discussion on the overlooked darling of the mRNA space: The plasmid.