FORMULATION ARTICLES
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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
Dr. John Lewis, Founder and CEO, Entos Pharmaceuticals, presents RNA Vaccine Development to Phase I.
Gain insights into overcoming the challenges in lipid nanoparticle (LNP) formulation, explore critical aspects of the process and analytical development of LNPs, and much more.
NxGen™ microfluidic technology enables controlled and precise assembly of high-quality, uniform LNPs, ensuring reproducible scale-up of RNA-LNPs while maximizing drug loading and particle quality.
Nutcracker Therapeutics’ Oreanna Thomas shares her takeaways from a pre-IND meeting for one of the company’s mRNA therapeutic candidates.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![GettyImages-1437855768-lipid-nanoparticle-lnp-mrna vaccine]( "Enabling Effective Passive And Active Immune Cell Targeting Strategies")
Targeted LNPs that bypass the liver and home to the spleen could reshape in vivo CAR T cell manufacturing. See the data behind the approach.
-
![GettyImages-2193391345-cryopreservation]( "How Operational Efficiency Shapes Late-Phase Manufacturability")
Prioritize operational efficiency over early-stage flexibility to scale advanced therapies. Standardized workflows and qualified shipping lanes reduce variability for predictable late-phase success.
-
![GettyImages-2270210340-lipid-nanoparticle-delivery-system]( "Extrahepatic Delivery Of mRNA-LNP To Spleen")
In vivo CAR-T approaches aim to reprogram T cells directly in the body using targeted lipid nanoparticles. Improved delivery to immune organs highlights new potential for scalable cell therapies.
-
![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.
-
![GettyImages-1311518492-vaccine-vial]( "Expanding Into New Fields Of “Cell-Grow-Culture” For mRNA Transfection")
Learn about one path forward to navigate the pitfalls with mRNA transfection and a medium to assist in lentivirus-mediated transduction of human mesenchymal stromal/stem cells (hMSCs).
-
![GettyImages-1288118586 cell development]( "Expectations On The Pathway To GMP For Gene-Modified Cell Therapies")
Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.
-
![GettyImages-950086574 drug development]( "Recommendations For Successful IND Approval Of RNA-LNP Drugs")
The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.
