Newsletter | November 12, 2025

11.12.25 -- Why We Still Haven't Solved mRNA Scale-Up

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Webinar: Addressing the Challenges of LNP Upscaling: A Reynolds Number-Driven Approach via Junction Mixing Technologies

Scaling lipid nanoparticle (LNP) formulations from lab to GMP production introduces challenges in uniformity and reproducibility. This webinar explores how KNAUER’s Impingement Jets Mixing (IJM) technology provides scalable, physics-based control through constant flow conditions. Learn how fluid dynamics inform LNP quality, enabling safe, efficient, and reproducible RNA therapeutic production from R&D to global manufacturing. Click here to learn more.

FEATURED EDITORIAL

Bridging RNA Innovation: A CEO's Guide To European Expansion

For RNA biotechs, Europe isn't just the next market — it's the ultimate test of strategy. Here's what CEOs need to know.

Why We Still Haven't Solved mRNA Scale-Up

While we can make lots of mRNA at a smaller scale, when it comes to scaling up to kg quantities of mRNA, our current batch processes leave a lot to be desired. Together, Stu Sundseth of Tune Therapeutics and Christian Dohmen of Ethris unpack the biggest barriers to scaling IVT to achieve the desired yield and quality of mRNA, offering their take on how the field is innovating to overcome these issues. 

Developing Exosome-Based RNA Therapeutics For CNS Regeneration

Inside the effort to use exosomes as natural nanocarriers that deliver RNA therapeutics safely across the blood–brain barrier to heal damaged neural tissue.

INDUSTRY INSIGHTS

Linear Scalability In Turbulent‐Jet Mixing For Nanoparticle Processing

Understand how turbulent-jet mixing ensures predictable and reproducible nanoparticle size and uniformity across all scales, accelerating development and regulatory readiness.

Optimized And Scalable LNP Composition For RNA Vaccine Delivery

Explore results from a study screening novel LNP formulations for physicochemical attributes, in vitro potency, and in vivo immunogenicity in both SARS-CoV-2 and influenza vaccine applications.

Building Bioanalysis Infrastructure For Modern Drug Development

Drug development accelerates with AI, DCTs, and adaptive protocols, but legacy CRO infrastructure lags. Platform-based systems enable speed, quality, automation, and continuous improvement.

Exploring RNA Structure And Ligand Interactions With MMS

Learn about using microfluidic modulation spectroscopy (MMS) to probe RNA base pair and ligand interactions in solution. This research explores the effects of lipid adducts on RNA structure and characterizes base pairing with MMS.

Sustainable Vaccine Manufacturing: Securing The Future Of Global Health

Explore how next-gen technologies, from mRNA platforms to digital tools, are transforming vaccine manufacturing to make it more sustainable, flexible, and accessible.

mRNA Process And Cost Modeling: A Tool To Optimize Process Development

Demand for mRNA-based medicine production continues to increase, as do investments in prophylactic and therapeutic indications. Explore a cost-model that compares all modalities.

AI Predictive Maintenance Prevents Batch Loss And Production Shutdown

Learn how AI-powered predictive maintenance prevented costly batch loss and production shutdowns in pharma manufacturing by detecting and fixing equipment issues before failures occurred.

Optimized Performance Model For Yield And Quality Of The mRNA Product

Optimize your mRNA production by identifying an optimum set of conditions for the IVT reaction that produces high-quality mRNA in high yield using a design of experiment (DoE) approach.

Navigating Challenges In Progressing Breakthrough RNA Therapeutics

RNA therapeutics hold immense promise for precision treatment, but their development faces challenges. A CDMO with adaptable platforms and flexible timelines can help reduce time and costs.

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Webinar: The future is now: are you keeping pace with oligo synthesis optimization?

The oligonucleotide market is rapidly evolving, expanding beyond rare diseases into larger patient populations. With over 40 years of experience, Cytiva helps streamline oligo development, manufacturing, and scale-up—whether you’re optimizing R&D or bringing processes in-house. Join this webinar to explore Cytiva’s latest oligo synthesis system, end-to-end workflow, and innovations shaping the future of RNA synthesis. Click here to learn more.

SOLUTIONS

Oligonucleotide Synthesis Solutions

mRNA Vaccines And Therapeutics

The Future Of mRNA Manufacturing

Accelerate Your Drug Development With A Global Partner

Nanoparticle Enabled Formulation And Drug Delivery Solutions

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Webinar: Accelerate your pDNA and mRNA process development

Discover how to achieve high-yield plasmid DNA (pDNA) production in this Cytiva webinar. The Fast Trak™ team shares a systematic approach to developing and scaling a pDNA process using E. coli OneShot Top10. Learn how design of experiments (DOE), optimized culture conditions, and the Xcellerex™ XDR-50 fermentor enable seamless scale-up from benchtop to pilot scale while maintaining yield, quality, and process control. Click here to learn more.