FORMULATION ARTICLES
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Nanosystems And Rare Diseases: Opportunities And Limitations
Nanosystems offer unique capabilities, enabling researchers to design precise, versatile delivery systems that address key challenges in rare diseases.
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The Potency Chains Of Events For mRNA/LNP Therapeutics
Potency in mRNA/LNP therapies depends on two chains: manufacturing/cold chain integrity and complex in vivo delivery. Breakdowns at any step — from stability to translation — can limit efficacy and safety.
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How Informal FDA Feedback Is Quietly Driving RNA Capital Allocation
Subtle FDA signals — especially in pre-IND talks — are quietly shaping RNA investment. Early regulatory feedback on CMC and comparability now drives how investors assess risk and allocate capital.
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From Pandemic Collaboration To Patent Litigation: BioNTech's Case Against Moderna
BioNTech’s new lawsuit against Moderna highlights the intensifying post-COVID mRNA patent wars, as companies clash over vaccine design, delivery technologies, and the future of RNA therapeutics.
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Mapping The LNP Frontier: The Quest For Better LNPs
Having previously served as the head of delivery sciences for Moderna pre-pandemic, Almarsson was part of the RNA-LNP delivery journey long before it was scientifically en vogue. That’s why I was excited to sit down with him to discuss the latest and greatest advancements in the RNA-LNP space. Here, we take stock of the developments he’s been watching in the passive and active delivery spaces.
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Inside The mRNA–LNP Patent Wars: A Q&A With Goodwin On Litigation, Strategy, And What Comes Next
Patent disputes around mRNA constructs and LNP delivery are intensifying. Goodwin’s Natasha Daughtrey and Bill Christiansen unpack litigation trends, IP strategy, and what RNA developers should expect next.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Learn about the drug development hurdles that must be overcome to deliver on the promise of mRNA.
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Technical summaries and detailed protocols for purity testing, sizing, sequencing and expression analysis of oligonucleotide-based active agents as well as protein and lipid-based delivery systems.
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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.
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Explore how to use and amplify pDNA from the development of recombinant proteins and viral vectors to advanced bio-therapeutics such as mRNA vaccines.
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Microfluidic mixing is one of the most effective means to formulate LNPs for its scalability and reproducibility. Explore LNP formulation, polishing, sterile filtration of mRNA-LNPs, and more.
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Learn more about issued guidelines on Critical Quality Attributes for IVT mRNA vaccines and biotherapeutics to focus on drug substance and LNP-encapsulated drug product assessment using an analyzer system.
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Manual LNP formulation introduces process variability that threatens particle quality and yield. As programs scale toward clinical production, maintaining strict control over CQAs becomes essential.