Newsletter | April 15, 2026

04.15.26 -- Defining Potency In The mRNA Space

SPONSOR

Personalized cancer vaccines are pushing immuno-oncology forward, but delivery and manufacturing hurdles still stand in the way. In this webinar, Cytiva explores how optimized ionizable LNPs can improve mRNA vaccine delivery, tolerability, and tumor response, while supporting small-scale clinical manufacturing strategies that help move PCV candidates from concept to clinic with greater confidence. Click here to learn more.

FEATURED EDITORIAL

The Monster Under The Bed: Defining Potency In The mRNA Space

How are we defining and measuring our product’s potency? This question, posed at a past CASSS mRNA Symposium, is far from straightforward, and, dear reader, based on the resulting discussion amongst regulators and panel members, it became clear we have a lot of different definitions of what potency even is in the mRNA space.

Plausible Mechanism Framework Changes Rare Disease Drug Development

Discover how the new FDA Plausible Mechanism Framework changes the game for rare disease research. This shift addresses unconventional programs by formalizing an approval pathway for individualized treatments of ultra-rare genetic diseases.

Dual Centrifugation And The Next Phase Of Lipid Nanoparticle Development

Dual centrifugation enables rapid, small-scale LNP development and screening with high encapsulation, reproducibility, and preserved RNA integrity. This offers a more flexible bridge between benchtop discovery and scalable manufacturing.

How Microfluidics And QbD Are Maturing LNP Manufacturing

CMC Consultant Sujit Jain and NanoVation CEO Dominik Witzigmann share their perspectives on the manufacturing technology advancements that have and will continue to meaningfully improve passive delivery of mRNA-LNPs.

INDUSTRY INSIGHTS

The Hitchhiker´s Guide To Creating Oligonucleotides From Start To Finish

Achieving high-quality results requires precision at every stage. Gain a clearer understanding of the complete mid-scale production workflow and essential quality control measures for your process.

Optimize Your Performance Model For mRNA Yield And Quality

Enhance your mRNA production by identifying optimal reaction conditions. Ascertain how to utilize a design of experiment approach to reliably achieve high-quality mRNA in significantly higher yields.

How Polymerase Selection Shapes IVT Outcomes

dsRNA contamination starts with polymerase choice. See how engineered RNA polymerases cut dsRNA by more than 10x compared to wild-type T7 in independent IVT testing.

Increasing Batch Size And Reducing Cycle Times For A Biologic

Strategic collaboration can transform manufacturing output. See how a focused partnership optimized production workflows to increase batch sizes and accelerate critical release timelines.

mRNA Manufacturing With Fed-Batch In Vitro Transcription

Milliliter-scale optimization reveals how controlled feeding and pH management can boost mRNA yields. Discover how real-time monitoring streamlines scale-up efforts for larger bioreactors.

Why ddPCR Is Becoming The Standard For Gene Therapy Biodistribution

Precision is critical in gene therapy. Learn why this digital quantification method is becoming the standard for reliable, defensible data across various tissues and clinical study phases.

SOLUTIONS

mRNA/LNP Development And Manufacturing Services

In Vitro Transcription For mRNA Production