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
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.
Dr. Michael Buschmann, George Mason University, presents an overview of molecular and colloidal ionization properties of lipid nanoparticle mRNA vaccines.
Dr. Jason Coleman, Clinical Application Scientist Lead with Precision NanoSystems, presents on an overview of the development and scale-up activities needed to progress this saRNA vaccine to the clinic.
There are many different criteria for selecting a CDMO for your mRNA products. Arcturus’ Qian Ruan explains that a product’s stage of development and the specific needs inherent to that phase of development should be an important guide for companies today, especially given the expansion of the outsourcing sector and the wide range of capabilities.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-597935610 cell and gene]( "Delivering The Promise Of Gene Therapy")
Gene therapies rely on efficient, precise methods of delivering genetic material. Examine how combining polymeric nanoparticles with CRISPR therapies is increasing the potential for improved treatment.
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![mRNA GettyImages-1356994684]( "Levers To Optimize The IVT Reaction For Increased mRNA Yield")
Mastering IVT yield requires balancing magnesium and nucleotide ratios. Learn how specific buffers and pyrophosphatase optimize mRNA synthesis for scalable, high-quality therapeutic production.
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![GettyImages-1409578453 LNP]( "Mixing Technology: Linear Scalability And Mixing Precision For Nanoparticle Formulation")
Find out how you can achieve precise control and linear scalability in nanoparticle formulation with mixing technology that minimizes batch-to-batch variability and simplifies the scale-up process.
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![GettyImages-1317697233-cancer-t-cells]( "A Novel RNA Lipid Nanoparticle Platform: Gene-Edited CAR T Cells For Off-The-Shelf Cancer Therapy")
We report on the use of a novel lipid nanoparticle (LNP) reagent in a validated protocol to achieve successful complex gene editing in primary T cells with high efficiency while maintaining high cell viability.
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![Worker Holding Vaccine Vial GettyImages-1403976499]( "LNP Formulation For mRNA Delivery")
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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![Worker Holding Vaccine Vial GettyImages-1403976499]( "Potent Immune Response With Vernal's LNP-mRNAs")
As mRNA medicine continues to evolve, understand how trusted manufacturing partners will continue to play a pivotal role in translating innovative concepts into clinical reality.
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![Scientists Discussing GettyImages-916075464]( "Is Standardization The Key To Scalable CGT?")
Experts note CGT programs often struggle due to limited operational readiness; early standardization supports scalable, reproducible, regulatory‑ready development and helps prevent late‑stage bottlenecks.
