FORMULATION ARTICLES
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Antibody–Oligonucleotide Conjugates, Part 4: Regulatory Considerations And Future Directions
This last article of the author's series on AOCs reveals regulatory perspective, analytical opportunities, the emergence of molecular quality by design, and the CMC challenges to address with future work.
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Protecting The Platform: Trade Secret Protection For RNA Biotech Companies
As RNA therapeutics grow more complex and collaborative, trade secrets are becoming an increasingly important part of protecting valuable platform innovation.
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How Should We Measure The True Potency Of RNA Therapeutics?
An RNA therapeutic can generate a strong molecular signal without producing the intended biological function. Let's look at how best to predict whether the RNA has completed its task.
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From Albumin To Oncology: Can Chemical Engineering Unlock Solid Tumor Delivery?
We discuss how selective albumin binding improved tumor delivery in preclinical studies and what these findings could mean for the future of siRNA-based cancer therapies.
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Beyond GalNAc: Reengineering siRNA For Extrahepatic Delivery
We discuss why effective extrahepatic delivery remains one of the field's biggest obstacles and how chemical engineering may provide a new path forward.
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Engineering CAR T Cells With mRNA-LNPs: Applying Oncology Learnings To Allergic Diseases
Targeted lipid nanoparticles (LNPs) could deliver mRNA encoding a CAR directly to T cells inside a patient with allergic disease. The potential implications extend beyond a single allergic condition.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Lipid nanoparticles enable precise, non-viral gene editing in T cells to achieve high HDR efficiency and viability in scalable workflows. Explore how this approach overcomes viral vector limitations.
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Explore key considerations for manufacturing RNA-LNP drug products surrounding process and analytical development, automation, environmental monitoring, and strategic collaborations.
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Cryopreservation should be integrated across the entire supply chain to ensure traceability, reduce risk at handoffs, and support consistent, scalable therapy development and delivery.
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Personalized cancer vaccines face a DNA production bottleneck. Synthetic approaches speed timelines, boost consistency, and simplify workflows to deliver individualized therapies faster.
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The shift from "scale-up" to "scale-out" in genetic medicine enhances production speed, revolutionizing pharmaceutical manufacturing and accelerating life-saving therapies for global patient populations.
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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.
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Lipid nanoparticles enable efficient gene editing in hard-to-transfect cells like T-cells and blood stem cells, which offers scalable, clinically relevant methods for developing advanced therapies for cancer and rare diseases.