FORMULATION ARTICLES
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![Global health safety regulation-GettyImages-2245658628]( "How Informal FDA Feedback Is Quietly Driving RNA Capital Allocation")
How Informal FDA Feedback Is Quietly Driving RNA Capital AllocationSubtle 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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![Judges deck-pcr coronavirus-GettyImages-1285766387]( "From Pandemic Collaboration To Patent Litigation: BioNTech's Case Against Moderna")
From Pandemic Collaboration To Patent Litigation: BioNTech's Case Against ModernaBioNTech’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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![compass on treasure map-GettyImages-157588143]( "Mapping The LNP Frontier: The Quest For Better LNPs")
Mapping The LNP Frontier: The Quest For Better LNPsHaving 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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![Patent Wars-GettyImages-491938817]( "Inside The mRNA–LNP Patent Wars: A Q&A With Goodwin On Litigation, Strategy, And What Comes Next")
Inside The mRNA–LNP Patent Wars: A Q&A With Goodwin On Litigation, Strategy, And What Comes NextPatent 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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![Human anatomy, medical, biology, science, healthcare-GettyImages-1458871453]( "The Future Of Kidney Disease Therapeutics: Bringing Nanomedicine To Nephrology")
The Future Of Kidney Disease Therapeutics: Bringing Nanomedicine To NephrologyNanomedicines 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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![Molecular biology, mRNA strands, genetics-GettyImages-2198118160]( "Engineering Translation: How tRNA Therapeutics Expand The RNA Toolkit")
Engineering Translation: How tRNA Therapeutics Expand The RNA ToolkitEngineered 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.
FORMULATION VIDEOS
In this clip, Sanofi’s Greg Troiano kickstarts our discussion on some of the advances he’s seen in the supply chain for linear mRNA-LNP products, both in terms of supply availability and supplier capability.
Together, Life Edit Therapeutics’ April Sena and Sanofi’s Troiano share their perspectives on raw material quality & IP-related considerations for managing the supply chain for next-generation RNA modalities.
Nutcracker Therapeutics’ Oreanna Thomas shares her takeaways from a pre-IND meeting for one of the company’s mRNA therapeutic candidates.
Three LNP experts from Sanofi, Hopewell Therapeutics, and BioNTech collectively discuss how far we’ve come in understanding the structure of our LNPs while also shedding light on the variables that have the greatest potential of causing shifts in our products’ structure/function.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-500323894 research tech]( "High-Throughput Lipid Separation For LNP Formulations")
Lipid nanoparticles (LNPs) carry immense potential as delivery systems. Learn about the development of isocratic and gradient methods for high-throughput separation of lipids used in LNP formulations.
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![KNAUER - IJM Tech]( "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.
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![Lipid Nanoparticles GettyImages-1437855772]( "Advancing RNA-LNP Therapeutics As An Alternative To Viral Vectors")
RNA-LNP therapeutics offer a flexible, transient alternative to traditional viral vectors for genetic medicine. Learn about the advantages of LNPs in safety, scalability, and payload versatility.
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![GettyImages-2151198847-lipid-nanoparticle-with-rna-strands]( "Advancing Cell Therapies With Lipid Nanoparticles")
Cell therapies, using reprogrammed immune cells, offer innovative treatments for diseases. Discover how lipid nanoparticles (LNPs) enhance these therapies by delivering RNA for gene modulation and next-gen treatments.
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![mRNA GettyImages-1428646288]( "Establishing Analytical Methods For mRNA-Based Therapies")
Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.
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![GettyImages-525440891-lab-research-development]( "Avoiding The Pitfalls Of LNPs And Complex Formulations")
Explore the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.
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![MSglassvials]( "Supporting Complex Manufacturing For Liquid And Lyophilized Drug Products")
Aseptic fill and finish operations gain efficiency and precision with modular isolator technology, inline weight checks, and lyophilization, which are ideal for mRNA-LNPs and other sensitive modalities.
