FORMULATION ARTICLES
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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.
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The Future Of Kidney Disease Therapeutics: Bringing Nanomedicine To Nephrology
Nanomedicines are solving the drug delivery problem in kidney disease. The next step: bridging the translational gap to advance these technologies into the clinic.
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Engineering Translation: How tRNA Therapeutics Expand The RNA Toolkit
Engineered tRNAs target translation itself — correcting shared errors like premature stop codons at the ribosome — to restore functional protein and redefine precision medicine by mechanism, not diagnosis.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Explore key considerations for manufacturing RNA-LNP drug products surrounding process and analytical development, automation, environmental monitoring, and strategic collaborations.
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Achieve the optimal nutritional balance with diverse supplements tailored for your specific bioprocess that can be added to maintain a nutritionally balanced medium.
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Learn about an HPLC-MS/MS method for detecting lipid impurities in lipid nanoparticles (LNPs) and why it is critical for quality control of LNP-based drug delivery systems.
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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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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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Explore challenges to the successful development of RNA-based drugs and vaccines as well as the advantages of utilizing lipid nanoparticle technology as a delivery platform for saRNA.
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Lipid nanoparticles enable efficient gene editing in hard-to-transfect cells like T-cells and blood stem cells, which offers scalable, clinically relevant methods for developing advanced therapies for cancer and rare diseases.