Newsletter | July 9, 2025

07.09.25 -- What Can mRNA Learn From Picasso?

 

 

 

FEATURED EDITORIAL

Pictures At An [mRNA]Exhibition: What We Can Learn From Picasso (Pt. 1)

In my presentation, I argued that there are three lessons we can learn from Picasso that will also help our own industry mature. In the upcoming weeks, I plan to unpack these lessons, highlighting specific instances in which I see our industry taking these lessons to heart and making progress — starting here with lesson 1: Being Innovative Comes After We Master The Basics.

 

Engaging FDA And EMA During mRNA Process Development

Panelists Tiffany Lucas and Ulrike Jägle address an audience question about when and how to approach the regulatory agencies for mRNA process development. In addition to listing the different FDA and EMA meeting opportunities available to sponsors, Jägle reminds us of one critical best practices sponsors shouldn’t forget when approaching the agencies.

 

Engineering The Next Generation Of LNPs For Advanced Therapeutics

Lipid nanoparticles (LNPs) face significant hurdles in clinical use due to challenges with their stability, manufacturing, and understanding how their complex characteristics impact therapeutic efficacy and safety.

 

INDUSTRY INSIGHTS

 

The Paradigm Shift: From Scale-Up To Scale-Out In Genetic Medicine

The shift from "scale-up" to "scale-out" in genetic medicine enhances production speed, revolutionizing pharmaceutical manufacturing and accelerating life-saving therapies for global patient populations.

 

5 Trends Impacting CMOs In 2025

In 2025, CMOs will navigate Annex 1 compliance, the BioSecure Act’s uncertainty, AI-driven drug development, supply chain challenges from tariffs, and pandemic preparedness strategies.

 

Intelligent Manufacturing Of mRNA Through The Power Of PAT

Learn how predictive models can monitor key CQAs, such as RNA concentration and nucleoside triphosphate consumption, and explore RBP and MIT’s vision for revolutionizing biomanufacturing.

 

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.

 

Improvement Of Self-Amplifying RNA With IVT Optimization

This study on optimizing In-Vitro Transcription (IVT) conditions for self-amplifying RNAs to achieve high yields, low residual dsRNA, and improved potency, showcases how these advancements can enhance RNA-based therapies.

 

5 Key Considerations For Companies Outsourcing Process Development

Venture capital in biotech remains strong, especially in cell and gene therapies. Discover five key factors to help companies choose between in-house and outsourced process development strategies.

 

What ASCO 2025 Means For The Future Of Oncology Trials

Review the ASCO 2025 Annual Meeting, highlighting oncology trials and the need for agile, globally capable CRO partners to navigate today’s evolving trial landscape.

 

Optimized Performance Model For Yield And Quality Of The mRNA Product

Optimize your mRNA production by identifying an optimum set of conditions for the IVT reaction that produces high-quality mRNA in high yield using a design of experiment (DoE) approach.

 

Efficient, Scalable Purification Of mRNA By Affinity Chromatography

Increasing demand for mRNA as a therapeutic product requires efficient, scalable purification methods. Here, a monolithic stationary phase is used to purify mRNA from a capping mix of Luc2 RNA.