FORMULATION ARTICLES
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![intelligent technology interface, robot chat-GettyImages-2279572840]( "Analytical Platforms: The Foundation Of The Next Generation Of RNA Therapeutics")
Analytical Platforms: The Foundation Of The Next Generation Of RNA TherapeuticsRNA therapeutics are entering a new era where analytical platforms drive scalability, regulatory confidence, manufacturing flexibility, and the development of increasingly complex products.
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![nucleic acid, DNA, RNA, purified protein-GettyImages-1350828873]( "A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA Products")
A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA ProductsNIST research introduces a gentle SEC method that separates dsRNA impurities from IVT mRNA by tweaking buffer pH, achieving 81.8% target recovery without transcript damage.
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![GettyImages-1316503044-dna-strand-double-helix-gene-editing]( "The Second Holy Grail Of Gene Editing: Large Knock-Ins")
The Second Holy Grail Of Gene Editing: Large Knock-InsExploring the race to achieve large gene knock-ins, emerging editing platforms, and how overcoming this challenge could unlock therapies for many inherited diseases.
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![GettyImages-1358847958]( "From Baby KJ To Global Access: The 3 Pillars Of Next-Gen mRNA Expansion")
From Baby KJ To Global Access: The 3 Pillars Of Next-Gen mRNA ExpansionObviously, the transition from RNA vaccines to therapeutics is an “expansion” all on its own; but to do this successfully, we need to expand our science, our products’ deliverability, and our patient access. In the following article, I highlight a few of the best practices and/or innovations that came up in conversation during this event that will play a significant role in helping us expand mRNA’s reach, both scientifically and therapeutically.
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![Leukodystrophy Awareness Month-GettyImages-2166836167]( "The Preclinical Gauntlet: Securing Capital And Designing Regulatory Pathways For Ultra-Rare ASO Drugs (Pt. 2)")
The Preclinical Gauntlet: Securing Capital And Designing Regulatory Pathways For Ultra-Rare ASO Drugs (Pt. 2)SynaptixBio CEO Dan Williams explains why funding, regulatory strategy, toxicology, and disciplined execution — not just science — determine success in advancing ultra-rare ASO therapies.
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![Cancer Detection-GettyImages-1477214805]( "Reprogramming The Tumor Microenvironment: Why RNA Immunotherapy Is Targeting Liver Metastases (Pt. 1)")
Reprogramming The Tumor Microenvironment: Why RNA Immunotherapy Is Targeting Liver Metastases (Pt. 1)RNA/DNA immunotherapy may overcome liver metastases by reprogramming innate immunity, restoring interferon signaling, and improving responses to checkpoint inhibitors.
FORMULATION VIDEOS
Discover the unparalleled flexibility and automation that sets the IJM NanoScaler Pro apart from other lipid nanoparticle systems.
A connected development pathway supports smoother scale-up and greater consistency for LNP-based therapeutics. Explore how integrated expertise across key stages helps teams accelerate progress.
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.
Russell Johnson, VP Formulation Research for RVAC Medicines, and Aalok Shah, Director of Formulation & Drug Delivery, Strand Therapeutics, share their expectations on which scientific advancements/characteristics will be most important for LNP-delivery of mRNA/RNA cargo in the future.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Lipid Nanoparticle mRNA Vaccine GettyImages-1418152448]( "Lipid Nanoparticle Compositional Analysis By UHPLC-CAD")
Explore results generated from an internal study using a proprietary mRNA-LNP formulation and UHPLC-CAD, a powerful technique for the analysis of compounds that do not contain chromophores.
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![Cryopreservation GettyImages-172640159]( "Integrate Cryopreservation Into the End-To-End Supply Chain")
Cryopreservation should be integrated across the entire supply chain to ensure traceability, reduce risk at handoffs, and support consistent, scalable therapy development and delivery.
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![Lipid Nanoparticles GettyImages-1437855772]( "How Lipid Nanoparticles Enable Next-Gen Delivery")
Cell therapy’s future depends on smarter gene delivery. Learn how lipid nanoparticles offer a scalable, cell-friendly alternative to electroporation and viral vectors for manufacturing efficiency.
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![GettyImages-1437856375-lnp-lipid-nanoparticle]( "Regulatory Considerations For Excipients Used In Lipid Nanoparticles")
Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.
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Manufacturing RNA-containing LNPs demands specialized expertise. Explore some of the challenges of RNA-LNP drug manufacturing and the advantages of outsourcing RNA-LNP formulations.
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![GettyImages-1622519985 cryopreservation, cold chain]( "Optimizing Leukapheresis Cryopreservation For CGT")
Discover how an automated cryopreservation process is reshaping the leukapheresis supply chain and driving progress in the future of cell and gene therapy.
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![GettyImages-1298788278 drug manufacturing]( "Improving U.S. Drug Supply Stability Through Continuous Nanoparticle Processing")
Learn about a continuous manufacturing platform designed to help overcome challenges in domestic pharmaceutical production, including scale-up barriers and production variability.
