Newsletter | April 1, 2026

04.01.26 -- The Evolving CMC Landscape For mRNA-LNPs

FEATURED EDITORIAL

mRNA Hot Takes: Ghost Peppers & Global R&D

Welcome to Advancing RNA’s mRNA Hot Takes, the show where we talk about serious RNA things, but with a spicy twist. Here, in episode 5, Advancing RNA's ARW sits down with Radar Therapeutics' Sophia Lugo and Entrée Bio's Michelle Lynn Hall to answer the (loaded) question: To do good science in the mRNA sector, should we be staying in the US?

Targeted Delivery – A Holy Grail For CRISPR Gene Editing

Precise CRISPR delivery remains the bottleneck to safer, more potent gene editing. Advances in LNP design, targeting strategies, and extrahepatic delivery are redefining what’s possible in vivo.

The Evolution Of Oligonucleotide Manufacturing: Engineering Considerations For Scale, Efficiency, And Facility Design

As oligos move toward larger indications, manufacturing shifts from chemistry alone to facility design—balancing scale, solvent safety, cost, and flexibility as SPOS, slurry, and enzymatic paths converge.

The Evolving CMC Landscape For mRNA-LNPs

In this Advancing RNA Live clip, CMC consultant Sujit Jain unpacks the levels of maturity he’s observed in process and analytical development, as well as supply chain. While vaccines and liver-targeting therapeutics boast what we can call a reproducible platform today, targeted LNP therapies introduce a handful of scale-up sensitivities and characterization hurdles.

INDUSTRY INSIGHTS

Benefits Of Isolator Technology In Fill-Finish

Isolator technology enhances sterility assurance, reduces contamination risk, improves operator safety, and supports regulatory compliance, making it essential for modern aseptic fill-finish operations.

Reducing Human Variability In Bioanalysis

Automation removes manual variability, creating consistent, repeatable processes that improve precision, strengthen compliance, and produce more reliable data for critical decisions.

mRNA Purification At Ambient Temperature

Explore how anion exchange chromatography with dual gradient elution enables efficient mRNA purification at ambient temperature.

Decipher mRNA Immunogenicity: Assessing Human Immune Response

Review strategies to assess the potential for human immune response following the administration of an mRNA therapeutic, the associated LNP, and the protein encoded for by the mRNA.

Transcribe RNA With Higher Purity And Activity Using Less Cap Analog

Enhance RNA manufacturing with HiCap T7 RNA Polymerase, which minimizes dsRNA, boosts expression, and reduces capping costs for superior therapeutic development.

SPONSOR

Webinar: Unlocking the next wave of cancer vaccines: Advancing mRNA-LNP delivery and small-scale manufacturing

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.

SOLUTIONS

Largest Global Network Of GMP Product Testing Laboratories

Understand Your Stability Programs

Customized Skid For Large Production Scale