Newsletter | November 5, 2025

11.05.25 -- 3 Must-Improve Areas Of mRNA Process Development

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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

4 Non-Viral Delivery Vehicles Expanding The Possibilities Of mRNA Therapeutics

While LNPs have emerged as the most promising non-viral delivery vehicles for mRNA therapeutics thus far, the field is rapidly expanding. To broaden mRNA’s applicability across a wider range of indications, companies are exploring innovative non-viral, non-LNP delivery vehicles, including polymers, engineered virus-like particles, and more.

3 Must-Improve Areas In mRNA Process Development

In this Advancing RNA Live clip, panelists Stu Sundseth, Marc Wolfgang, and Christian Dohmen each provide their take on the most critical areas for improvement in mRNA process development.

INDUSTRY INSIGHTS

Navigating The Regulatory Landscape Of mRNA-Based Therapeutics

Explore the evolving regulatory landscape of mRNA therapeutics in the EU and US, as well as learn key distinctions and strategic opportunities to optimize your mRNA drug development pipeline.

Nanoscale Technology's Potential: A Fireside Chat With Industry Leaders

Nanoform CEO Edward Haeggstrom and Shawn Davies, head of drug delivery, biopharmaceuticals development, AstraZeneca, discuss the potential of nanoscale medicines and delivery devices.

Recommendations For Successful IND Approval Of RNA-LNP Drugs

The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.

Scale-Up And Production Of Key Lipids Used In mRNA Delivery Systems

Discover key strategies for overcoming challenges in the industrial-scale production of ionizable and PEG lipids to optimize mRNA vaccine formulation and address critical manufacturing requirements.

Selection, Evaluation Of Hybridization Capture Probes For LC/MS Analysis

To overcome challenges in oligonucleotide LC/MS bioanalysis, consider optimizing probe design by evaluating alternative chemistries like PNA for improved recovery and chromatographic performance.

Real-Time Monitoring Of Higher-Order Structure Of RNAs

Learn how this biophysical characterization strategy can enhance RNA therapeutic candidate screening and formulation development through a deeper understanding of RNA structure under native conditions.

Reducing Risk In mRNA Therapeutic Development

Advancements in purification, delivery mechanisms, and stability during storage and transport will enable the future of mRNA-based therapies.

How To Successfully Control The Upscaling Of Your LNP Formulation

Discover key strategies for controlling LNP formulation and upscaling. Explore the science behind lipid nanoparticles, critical parameters, and achieving effective turbulent mixing for optimal outcomes.

Fast And Efficient Extraction Of mRNA From IVT Mixtures

Here, a fast and efficient way to purify polyadenylated mRNA using affinity chromatography on the CIMmultus® Oligo dT column is presented.

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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.

SOLUTIONS

Contract Services To Optimize Continuous Nanoparticle Processing

Fill/Finish Capacity Update January 2025

Master Your mRNA Manufacturing

OligoProcess Oligonucleotide Synthesizer Product Overview

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Join us in a discussion around the role mRNA technology will play in the future of Canadian healthcare and how misinformation, polarization, and political partisanship is shaping its global future. The community is invited to an exclusive screening of The Messenger, a documentary showcasing the origin of mRNA technology, followed by a panel featuring mRNA pioneers and leading experts in public health and regulation.