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
mRNA therapeutics are applicable to cancer immunotherapies, infectious diseases, and other indications that require protein replacement therapy or antibodies.
Though there are a lot of exciting advancements being made with novel lipid chemistries, CMC Consultant Sujit Jain provides an important reality check for us: These innovations break established platforms, requiring fresh process development, complex impurity profiling, and new vendor qualifications.
Explore the future of nucleic acid and nanoparticle-based therapeutics, including mRNA, CRISPR, and gene editing, as experts discuss innovative solutions for complex health challenges.
Learn a validated, end-to-end protocol for producing high-quality in vitro transcription (IVT) mRNA for preclinical research. Find out how to optimize sequence design, small-scale synthesis, and more.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Evonik1]( "How mRNA Technology Is Shaping The Future Of Medicine")
Discover how mRNA technologies open the doors to a whole range of new gene therapies and the role of lipid nanoparticles (LNPs) in current and future developments.
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![GettyImages-1622519985 cryopreservation, cold chain]( "Regulatory Readiness Is Built Early")
Building regulatory readiness early in cell and gene therapy development protects product integrity, prevents costly delays, and secures long-term program viability.
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![Lipid nanoparticle mRNA vaccine-GettyImages-1418152448]( "Lipids CDMO Services: Custom Excipients Tailored To Your Needs")
Advance your lipid‑based programs with a CDMO partner equipped to deliver customized excipients, proven scale‑up expertise, and reliable support from early development through commercialization.
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![research-drugdevelopment-GettyImages-2254140660]( "mRNA LNPs Drive Safe, Effective Repeat Dosing In Disease Models")
Well-designed lipid nanoparticles enable safe, efficient delivery. OVA-based models show how formulation choices shape efficacy, safety, and anti-tumor outcomes in melanoma research.
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![Doctor Preparing Injection Site GettyImages-1379313214]( "How LNP Technology Meets The Delivery Need Of saRNA Vaccines")
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 Nanoparticle mRNA Vaccine GettyImages-1418152448]( "Fit-For-Purpose Lipids Can Accelerate, Scale, And Improve RNA-LNP Drugs")
Emerging biotech companies are investing in novel delivery capabilities to address different modalities' needs and extra-hepatic delivery. Explore steps to accelerate commercial nanomedicine delivery.
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![GettyImages-1326811027-lab]( "New To mRNA Manufacturing? Considerations For Starting")
Explore considerations for starting mRNA manufacturing related to the following topics: DNA template, mRNA product - IVT, mRNA product - purification, LNP encapsulation, and fill-finish.
