Newsletter | December 3, 2025

12.03.25 -- CMC Challenges In The Development Of Conjugated LNP Platforms

SPONSOR

Webinar: Robust and Cost-Effective mRNA Capping: Critical Quality Attributes and Manufacturing Strategies

Join Roche experts to explore advancements in scalable RNA manufacturing. This webinar highlights the role of capping strategies in ensuring RNA stability and translational efficiency at industrial scales. Attendees will gain insights into adopting new technologies and materials—such as Roche’s GMP Grade Vaccinia Capping Enzymes—and learn best practices for scaling mRNA synthesis from milliliter to liter volumes. Click here to register.

FEATURED EDITORIAL

Overcoming CMC Challenges In The Development Of Conjugated LNP Platforms For In Vivo CAR-T Therapy

Overcoming CMC hurdles is key to advancing conjugated LNP platforms for in vivo CAR-T therapy, enabling scalable, precise mRNA delivery to T cells while maintaining stability, potency, and regulatory compliance.

Why Current dsRNA Analytics Don't Quite Cut It

In this Advancing RNA Live segment, several speakers raise concerns about the industry's ability to accurately measure impurities, particularly dsRNA, arguing that current analytics are insufficient, especially for high-dose therapeutics.

Inside NeoVac's LNP Formulation Strategy: Challenges, Innovation, And What Comes Next

NeoVac CEO Jan Egberts, MD, discusses the science, regulation, and innovation shaping next-gen LNPs—and why true progress in mRNA therapeutics may depend more on understanding than on AI.

INDUSTRY INSIGHTS

Antisense Oligonucleotide Extraction Optimization Reveals Differences

Our findings provide critical insights into refining ASO extraction protocols, which can enhance the accuracy of downstream analyses and support further research into ASO-based therapeutics.

Laminar And Turbulent Mixing Techniques For LNP Formulations Scale Up

Explore the critical factors in scaling up lipid nanoparticle (LNP) formulation, comparing the advantages and limitations of both laminar (microfluidic) and turbulent (tee and jet) mixing technologies.

Structural Characterization Of RNA And Detection Of RNA-Ligand Binding

Delve into the intricacies of riboswitch behavior and ligand interactions and gain valuable insights into gene regulation and potential therapeutic targets.

How Are Therapeutic Radiopharmaceuticals Advancing Precision Oncology?

By directing radioactive isotopes straight to diseased tissue, these agents deliver potent, localized treatment while sparing healthy cells, a major leap forward for patients with treatment-resistant cancers.

Developing A Scalable RNA-LNP Drug Product For Clinical Translation

Accelerate essential process development activities with instrumentation solution allowing for highly reproducible and scalable production of RNA-LNPs.

Increasing Productivity Of pDNA DSP Using Displacement Chromatography

Here, two distinct polishing processes using monoliths are compared: bind-elute (BE) and the more recently developed sample displacement purification (SDP).

Optimizing mRNA For Success: Enhancing Stability, Delivery, And Efficacy

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

Accelerate Your pDNA And mRNA Process Development

Explore a structured approach to optimizing and scaling plasmid DNA production using E. coli, with insights into key growth parameters, benchtop feasibility, and pilot-scale performance.

Lessons In Scaling Lipids Production And Purification

The rapid scale-up of mRNA drug manufacturing exposes supply chain vulnerabilities for key ingredients like lipids. Resilience is now critical.

Co-Precipitation Of Metal Carbonate Templated Protein Microparticles

Explore the automated production of protein microparticles using an innovative method that offers a standardized and scalable solution for co-precipitation in biopolymer particle fabrication.

Partnering To Build A Biomanufacturing Certification Program

Jubilant HollisterStier partnered with SCC to launch a biomanufacturing program, building career pathways for Spokane’s growing life sciences and pharmaceutical manufacturing sector.

SPONSOR

Webinar: Advancing targeted in vivo LNPs: Five practical considerations to move from concept to clinic

As targeted in vivo delivery grows more complex, every decision — from payload design to conjugation, analytics, and process strategy — shapes clinical success. In this webinar, Cytiva experts share five practical considerations for advancing targeted in vivo LNP programs, drawing on ARPA-H experience to reveal proven approaches that improve robustness, scalability, and clinical readiness. Click here to learn more.

SOLUTIONS

mRNA Raw Materials To Scale Up Your Manufacturing

Nanoparticle Enabled Formulation And Drug Delivery Solutions

A CRO Accelerating Bioanalysis

Jet-Based Nanoparticle Formulation At Research Scale

Your Roadmap For Efficient Processes

Centralized Data Aggregation Software