Newsletter | December 11, 2024

12.11.24 -- Navigating the "Holy Trinity" of RNA Structure, Process, & Biology

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With a combined 20-year track record in the manufacturing of lipids, LNP, and mRNA, MilliporeSigma offers customizable mRNA-LNP CDMO services to meet your unique needs from pre-clinical to commercialization. Select integrated services from drug substance to Fill & Finish or individual components tailored to your project. Download the infographic to learn more!

FEATURED EDITORIAL

Navigating The "Holy Trinity" Of RNA Structure, Process, & Biology

During our hour-long conversation, Sagaert and I covered a lot of ground on the current state of the industry. But given his background in quality, it shouldn’t come as a surprise that our conversation ultimately gravitated back to some of the biggest questions we currently have and need to answer about our product’s structure and function — and how to adequately demonstrate this critical knowledge to regulators.

Tune Therapeutics On Clinical Readiness, Technology Adoption

Heidi Zhang, Ph.D., explains Tune Therapeutics' epigenetic approach to gene therapy and how the company is preparing its lead candidate for the clinic, as well as it's modular approach to automation.

Emerging Partnership Trends In Oligo-Based Medicines

The oligonucleotides sector is quickly evolving and seeing more industry partnerships than ever before. We caught up with DeciBio's Carl Schoellhammer and Phillip Leclair for their analysis.

Is Cold Chain Really A Challenge Facing mRNA Therapeutics?

mRNA product storage can be challenging due to extremely low temperature requirements. Here, Joseph Barberio of Strand Therapeutics and Christian Moreno of Nutcracker Therapeutics share their take on existing cold chain challenges.

INDUSTRY INSIGHTS

The Future Of mRNA: Four Key Focuses For Industry

Compared to traditional protein-based therapies, mRNA drugs exhibit unique pharmacokinetic profiles and can be rapidly developed, making overcoming their challenges critical for the industry.

Best Practices In Aseptic Sampling To Improve Quality In Bioprocessing

Learn the key aspects of aseptic sampling, appropriate methods and circumstances to perform sampling, and the impact of a platform and sample containers on assay results and process dynamics.

Navigating The Regulatory Maze: Fundamentals For Drug Development

Learn about key regulatory concepts and ways to accelerate and reduce risk throughout the drug development journey. 

Establishing Reproducible Polymer Nanoparticle (PNP) Manufacturing

The HIT SCAN platform revolutionizes PNP development for gene therapy by addressing manufacturing reproducibility, enhancing scalability, and unlocking safe, efficient, and versatile delivery systems.

TFF Cassettes With 100 kDa Membranes For RNA And LNP Applications

This study showcases the performance of regenerated cellulose flat sheet membranes with a 100 kDa molecular weight cutoff for UF/DF of RNA molecules by TFF.

Transferring From Microfluidics To A Turbulent Mixer

What solutions did the client featured in this case study find when they sought help in transferring their formulation process to a turbulent Impinged Jet Mixing (IJM)?

Fast Track RNA-LNP Drug Development By Lowering The Lipid Barrier

Fast-track RNA-LNP development, streamline screening with off-the-shelf ionizable lipid mixes, and utilize validation strategies to generate reproducible and scalable LNPs for lead candidates.