Newsletter | October 15, 2025

10.15.25 -- How U.S. Policy Upheavals Are Pushing The mRNA Industry To Adapt

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FEATURED EDITORIAL

Reclaiming mRNA's Story: How U.S. Policy Upheavals Push Us To Adapt

I’d like to believe everyone reading Advancing RNA already knows that mRNA is the greatest. So, this article isn’t going to outline why the U.S. government’s current efforts to disparage mRNA are harmful. Rather, I’d like to focus on how these policies are impacting our industry in both positive and negative ways — starting with a few takeaways I gleaned from a discussion at RNA Leaders. 

Contract Manufacturing Outsourcing Trends For Advanced Therapies

Contract manufacturing continues to emerge as the widely adopted model for bringing cell therapies, gene therapies, RNA therapeutics, and oligonucleotides to patients worldwide.

The Case for Extracellular Vesicles

While EVPs (engineered viral-like particles) and extracellular vesicles (EVs) are still emerging technologies, panelists explain how developers can navigate regulatory expectations by adapting lessons learned from established viral vector products. Additionally, Aegle’s Gloria Matthews explains the benefits of working with EVs in comparison to LNPs.

INDUSTRY INSIGHTS

Regulatory Frameworks For mRNA Therapeutics

The RNA therapeutics and vaccines market has grown rapidly, driven by siRNA and mRNA technologies. Explore how these advancements are now being applied to cancer vaccines and innovative therapeutics.

Evolving Into Biopharma 4.0: A Stepwise Journey Of Digital Transformation

You don’t need to make huge investments to shorten time-to-market. Watch to discover how incremental steps can transform your processes using digitalization and automation.

Choosing A CDMO: Three Considerations For New Drug Developers

The greatest challenge in drug development can be finding a team capable of carrying a molecule through the complexities that lie between the research lab and the patient’s bedside. Discover three considerations that build a foundation for partnership.

Continuous Nanoparticle Manufacturing For Gene Editing Delivery

mRNA-LNPs are a promising strategy for delivering gene-editing components. Learn how a continuous manufacturing platform can address the scalability and reproducibility challenges of this process.

Understanding Microfluidic Platforms For Scaling Nanoparticle Production

Learn about the benefits of microfluidics for nanoparticle production over traditional methods as well as scaling nanoparticle production for clinical or industrial use.

How To Partner With Your CRA For Best Trial Outcomes

Rethink your relationship with your CRA—they're more than a monitor. Build a proactive partnership for smoother trials, creative problem-solving, and achieving strong data quality.

High-Throughput Lipid Separation For LNP Formulations

Lipid nanoparticles (LNPs) carry immense potential as delivery systems. Learn about the development of isocratic and gradient methods for high-throughput separation of lipids used in LNP formulations.

Nanoforming Biologics, GLP-1s: From I.V. To Sub Q And Inhaled Delivery

Nanoforming enables new delivery routes for biologics and peptides to simplify dosing, enhance patient comfort, and reduce healthcare costs.

SOLUTIONS

RNA Therapies

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