FORMULATION ARTICLES
-
Validation Of A RIG-I–Based Functional Assay For Quantitative Detection Of Double-Stranded RNA Impurities In mRNA Drug Substance
A validated RIG-I assay adds a biology-informed layer to dsRNA testing by quantifying immunogenic impurities in IVT-derived mRNA therapeutics for deeper functional insight.
-
Suppressor tRNA Therapeutics: A New Frontier In Treating Genetic Disease
Suppressor tRNAs could unlock a scalable new way to treat genetic diseases caused by nonsense mutations, restoring full-length proteins across multiple indications.
-
Engineering Transient In Vivo CAR-T: Extending Expression, Expanding Access, And Rethinking Immune Reset
In this Q&A, Michael Lam, Ph.D., explores how circular RNA and targeted delivery extend transient CAR expression to enable deep B-cell depletion and controllable immune reset.
-
Engineering Repeat-Dose RNA: Engineering Around Immune Recognition In Repeat-Dose RNA Therapeutics
Designing repeat-dose RNA means engineering around immune recognition — optimizing payloads, purity, and delivery early to sustain efficacy, tolerability, and durability across multiple administrations.
-
A Novel Co-Tethered Transcription Platform For High-Yield, High-Purity mRNA Synthesis
Co-tethered transcription boosts mRNA yield and purity by organizing transcription machinery, reducing dsRNA impurities, and streamlining production for scalable RNA therapeutics.
-
A New Approach To RNA Synthesis And Purification: Rethinking A Persistent Bottleneck
Photocleavable supports enable light-triggered RNA release, reducing reliance on chromatography and streamlining synthesis, scalability, and purity for complex RNA therapeutics.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
Choosing between turbulent and microfluidic mixing methods in your lipid nanoparticle (LNP) production can have a significant impact when scaling up production.
-
Lipid nanoparticles (LNPs) offer a robust solution for nucleic acids. The NanoScaler system optimizes this technology, enabling scalable and reproducible LNP formulations for diverse applications.
-
Explore ongoing work to harness different types of HDR templates in order to build cutting-edge systems with the potential to enable point-of-care cell and gene therapy manufacture.
-
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.
-
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.
-
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.
-
As pharma companies aim to overcome development obstacles, it is important to incorporate GMP expertise alongside novel technologies that can enhance the properties of APIs and dosage forms.