FORMULATION ARTICLES
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            Beyond LNPs: 4 Non-Viral Delivery Vehicles Expanding The Possibilities Of mRNA Therapeutics
While LNPs have emerged as the most promising non-viral delivery vehicles for mRNA therapeutics thus far, the field is rapidly expanding. To broaden mRNA’s applicability across a wider range of indications, companies are exploring innovative non-viral, non-LNP delivery vehicles, including polymers, engineered virus-like particles, and more.
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            Translating An Early-Stage mRNA Therapeutic Into The Clinic
In the following Q&A, Ethris CMO Thomas Langenickel shares some of his biggest questions and observations about the evolving mRNA therapeutics space that are the most impactful in translating early-stage RNA candidates into the clinic — particularly when that drug product boasts a novel formulation.
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            Engineering The Next Generation Of Lipid Nanoparticles 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.
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            Is The mRNA Payload The Real MVP of Targeted Delivery?
As one delightfully colorful quote from a panel discussion at the AMM Ascent meeting last fall reminds us, there’s a lot more to be explored, discussed, and understood as it relates to the mRNA cargo’s role in targeted delivery.
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            Learning From Oligos: Delivery & Clinical Strategies For mRNA Therapeutics
Those of us who attended the Alliance for mRNA Medicines’ inaugural Ascent conference last fall had the opportunity to hear from Zdravka Medarova of TransCode Therapeutics on her experiences working in the oligo sector. Here, I summarize some of her learnings and/or suggestions for the encoding RNA field as we set out to develop mRNA therapeutics for oncology.
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            Courtroom Clash: Inside The High-Stakes World Of mRNA Patent Litigation
Here, Shores provides the “who’s who” and “what’s what” behind some of the hottest legal cases to hit the headlines in the mRNA space to-date, as well as why these cases are or could be significant to companies commercializing mRNA products in the future.
 
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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RNA therapeutics hold immense promise for precision treatment, but their development faces challenges. A CDMO with adaptable platforms and flexible timelines can help reduce time and costs.
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The path to regulatory approval for LNPs demands carefully considered strategies. By adopting proactive and strategic approaches, developers can overcome regulatory hurdles on the path to approval.
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Advancements in purification, delivery mechanisms, and stability during storage and transport will enable the future of mRNA-based therapies.
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With adjustable components and increased stability during bloodstream circulation, LNPs are significantly advancing drug development and delivery, particularly for mRNA vaccines.
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Here, we highlight three important process considerations across the RNA-LNP manufacturing workflow which includes limit size behavior, in-line dilution and downstream tangential flow filtration (TFF).
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Explore considerations for starting mRNA manufacturing related to the following topics: DNA template, mRNA product - IVT, mRNA product - purification, LNP encapsulation, and fill-finish.
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We aim to highlight that commercially available LNP reagent mix, GenVoy-ILM, is an accessible and easy-to-use LNP formulation that allows for rapid preclinical development of RNA vaccines.