FORMULATION ARTICLES
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Analytical Platforms: The Foundation Of The Next Generation Of RNA Therapeutics
RNA 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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A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA Products
NIST 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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The Second Holy Grail Of Gene Editing: Large Knock-Ins
Exploring 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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From Baby KJ To Global Access: The 3 Pillars Of Next-Gen mRNA Expansion
Obviously, 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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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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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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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By following some of the best practices in freezing mRNA, you can effectively balance product quality, cost-effectiveness, process safety, and efficiency.
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Explore the potential of polymeric nanoparticles (PNPs) as an alternative to viral vectors. PNPs offer design flexibility, enabling larger payloads, targeted release, and minimized side effects.
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Discover how self-replicating RNA (srRNA) can revolutionize vaccine development with sustained protein expression, lower doses, and fewer side effects to advance next-gen RNA therapeutics.
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Learn how optimizing LNPs can help overcome drug-delivery challenges, unlocking potential new genomic medicines in a shorter time.
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Explore the challenges to effective delivery of drugs to the eye, intricacies of ophthalmic drug delivery, and advantages of nanoparticles as an enabling technology for ocular drug-delivery systems.
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Dive into a study that details how a single-pass tangential flow filtration system can achieve a tenfold concentration of liposomal nanoparticles in under 20 minutes.
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Early integration of standardized, GMP-aligned cryopreservation improves consistency, documentation, and scalability in advanced therapy programs as they progress toward regulatory submissions.