Newsletter | August 13, 2025

08.13.25 -- Designing Effective Multivalent mRNA Therapies: Regulatory Considerations

FEATURED EDITORIAL

Ancient Molecule, Modern Medicine: The Science, Strategy, & Stakeholders Behind tRNA Therapeutics

As we all know well, “unearthing” our molecules’ potential poses numerous technical and business-related challenges for young biotech companies. Here, Werner and I continue our conversation, unpacking some of these internal and external challenges the company is navigating as it strives to bring tRNA to the commercial market.

 

Designing Effective Multivalent mRNA Therapies: Key Regulatory Considerations

How many mRNAs are too many in a multivalent therapy? In this clip, Eliquent Life Science’s Tiffany Lucas and CureVac’s Ulrike Jägle delve into this question, emphasizing the factors that are essential for regulatory success and patient benefit.

 

Tales From The Trenches: Developing Potency Assays Outside Big Pharma

Lessons learned from developing potency assays to detect activity and variation for cell- and receptor-mediated products — beyond the comforts of a well-heeled company.

 

INDUSTRY INSIGHTS

 

Spectroscopic Insights Into RNA Modifications In LNP Formulations

Understand how Microfluidic Modulation Spectroscopy (MMS) provides early insights into RNA degradation within LNP formulations, offering a label-free approach to monitoring chemical integrity.

 

Top 5 Approaches To The Bioanalysis Of Oligonucleotides

Evaluate the strengths and limitations of each bioanalysis method carefully to choose the most effective strategy for your clinical study.

 

The Future Of RNA: Clinical Strategy And Global Opportunity

Gain a timely look at the state of RNA therapeutics, and discover how innovation in delivery technologies, regulatory strategy, and partnership models is shaping the next generation of RNA-based medicines.

 

How mRNA Manufacturers Disrupt The Industry

Learn how biopharmaceutical companies can apply proven strategies to overcome hidden complexities in mRNA production, and discover solutions that can help you rapidly design and build a SU facility.

 

Enabling Continuous Manufacturing For CAR-T And LNP-Based Therapies

Breakthrough therapies are challenged by complex, batch-based manufacturing. Learn about an integrated system that enables continuous processing for improved consistency and reduced manual handling.

 

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.

 

Introduction To mRNA Manufacturing

The SARS-CoV-2 virus has changed the course of scientific research around mRNA. Learn about mRNA manufacturing, the structure of an mRNA molecule, RNase-free considerations, and more.

 

Optimizing mRNA: A Guide To Enhanced Stability, Delivery, And Efficacy

RNA offers exciting potential for vaccines, gene therapies, and personalized medicine, but challenges related to stability, delivery, and manufacturing persist.

 

New Hope For Neuronal Diseases With PNP-Based Gene Therapy

A new polymer nanoparticle (PNP) system enables targeted delivery of large genetic payloads to neuronal cells, advancing gene therapies for NF1 and other nervous system disorders.