Newsletter | March 5, 2025

03.05.25 -- The Latest & Greatest Innovations In mRNA-LNP production

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Join Advancing RNA Live for a deep dive into mRNA-LNP development, tackling key CQAs, manufacturing challenges, and the need for innovation in analytics, PAT, automation, and more. Explore strategies to enhance quality at smaller scales and navigate the future of advanced manufacturing. Reserve your spot for this free digital event happening March 13th!

FEATURED EDITORIAL

Cultivating A Thriving mRNA Ecosystem: Key Initiatives & Future Directions

Overall, I felt that the following initiatives/talking points were demonstrative of the types of creativity and symbiosis that we will need much more of in the near and long-term to foster a healthy and fruitful RNA ecosystem. 

FDA Finalizes Guidance On The Advanced Manufacturing Technologies Designation Program

The FDA released final guidance on the Advanced Manufacturing Technologies Designation Program at the end of December. This article shares a summary, analysis, and how it compares to the 2023 draft.

The Latest And Greatest Technological Innovations In mRNA-LNP Production

In this segment, Replicate Biosciences’ Andy Geall, Qian Ruan, & Alex Aust identify the most promising technological and raw material innovations that are influencing the drug substance and drug product production processes at CDMOs.

INDUSTRY INSIGHTS

Determining RNA Integrity And Purity By Capillary Gel Electrophoresis

To ensure mRNA product quality, it's important to confirm the integrity of the RNA. Examine the results of a study challenging the performance of the CGE method in assessing mRNA integrity and purity.

Alternatives To CRISPR-Cas9: Nucleases For Next-Gen Therapy

Alternatives to CRISPR-Cas9 address limitations like delivery challenges and off-target effects. Emerging nucleases offer improved specificity, smaller sizes, and therapeutic applications.

Probing RNA Base Pairing And Ligand Interactions In Solution With MMS

Discover why Microfluidic Modulation Spectroscopy (MMS) is a novel, label-free, solution-based infrared technique for probing RNA base pairing and ligand interactions.

Improving Toxicology Testing For Inhalation Products

By embracing new approach methods, regulatory agencies can revolutionize toxicology testing. These methods can be adapted for various medications, including inhalers and nasal-administered drugs.

mRNA's Next Frontier: Modular Manufacturing For RNA-LNP Therapies

Explore constructing a modular RNA-LNP GMP facility using Cytiva's FlexFactory™ process train in a KUBio™ environment to scale RNA-LNP therapies.

Scaling Of Impingement Jets Mixing For LNP Drug Production

Delve into the intricacies of Impingement Jets Mixing (IJM) technology and its pivotal role in the scalable and reproducible production of Lipid Nanoparticles (LNPs) for drug delivery.

Lessons In Scaling Lipids Production And Purification

The speed at which mRNA drug products are developed and manufactured at large scale is astounding, yet it has highlighted supply chain vulnerabilities for required pharmaceutical ingredients such as lipids.

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.