Newsletter | September 3, 2025

09.03.25 -- CQA Assessment Of LNP-Encapsulated IVT mRNA

FEATURED EDITORIAL

The RNA Synthesis Spectrum: Between Solid-Phase Roots & A Hybrid Enzymatic Future

There were two additional takeaways I had following my conversation with Kuchimanchi, each of which depicts where there still exists quite a bit of dynamism for an industry which can claim an “established” manufacturing paradigm.

Bioinformatics In mRNA Development: Classification And Integration Conundrums

As both Advancing RNA Live speakers point out in this segment, the MHRA guidance focuses deeply on the critical role bioinformatics and AI/ML approaches will play in the development of personalized immunotherapies. Here, Eliquent Life Sciences’ Tiffany Lucas and CureVac’s Ulrike Jägle address the biggest challenges they anticipate companies will face in meeting the agencies’ recommendations.

INDUSTRY INSIGHTS

Targeted LC-MS/MS Detection Of Lipid Impurities In Lipid Nanoparticles

Learn about an HPLC-MS/MS method for detecting lipid impurities in lipid nanoparticles (LNPs) and why it is critical for quality control of LNP-based drug delivery systems.

Unpacking The Importance Of Lipid Nanoparticle Production Platforms

Batch processing platforms for LNPs lack efficiency, appropriate controls, and yield optimization. Continuous manufacturing platforms may address some of those issues.

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.

Utilizing Nanoparticle Technologies For A More Sustainable Value Chain

The pharma industry is identifying ways to make processes more sustainable. Learn how nanoparticle engineering technology can both empower sustainability goals and lead to better patient outcomes.

Talent And Supply: Building A Foundation For The Future Of Biopharma

Read how to create future-ready facilities supported by advanced scientific knowledge and a secure supply chain that can handle the unprecedented demands and constraints of a post-COVID world.

JHS And Groninger's Partnership Drives Pharma Innovation, Local Growth

JHS and Groninger’s partnership powers expansion with advanced aseptic filling lines, driving innovation, quality, and community growth through shared values and strategic collaboration.

CQA Assessment Of LNP-Encapsulated IVT mRNA

Learn more about issued guidelines on Critical Quality Attributes for IVT mRNA vaccines and biotherapeutics to focus on drug substance and LNP-encapsulated drug product assessment using an analyzer system.

Scaling Up Your E. Coli pDNA Process

Discover a systematic approach to scalable plasmid DNA production using E. coli OneShot Top10, which features DOE-driven optimization and key insights for efficient biomanufacturing success.

A New Centre For Continuous mRNA Manufacturing

Explore how a partnership between academia, regulatory agencies, and manufacturing organizations has the potential to reshape the way we produce and distribute mRNA-based therapies.

SPONSOR

The PDA Pharmaceutical Microbiology Conference 2025 marks two decades of advancing microbiological science and practice. This milestone event brings together the global microbiology community, including experts from industry, academia, and regulatory agencies, to explore the evolving landscape of pharmaceutical microbiology. This year’s theme, Microbial Resilience: Today’s Response, Tomorrow’s Plan, reflects our focus on navigating present-day challenges while building robust strategies for the future.

SOLUTIONS

mRNA Capabilities

Organ On A Chip: Advancing New Approach Methodologies

ÄKTA Oligosynt Oligonucleotide Synthesizer Product Demo

Tissue Adenosine Distribution-Guided Gene Selection

AuroraTX: Ultra-Sensitive, Precise Structural Biomolecules Measurements

SPONSOR

As additional mRNA therapeutics makers progress toward and into the clinic, we're gathering more knowledge about what makes our mRNA products "tick," and how our processes impact the overall quality of our products. Join this expert panel for a timely discussion in the mRNA therapeutics space. Registration is free thanks to the support of Millipore Sigma.