FORMULATION ARTICLES
-
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.
-
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.
-
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.
-
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.
-
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.
-
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
-
Fragmented pre‑clinical supply chains create avoidable delays and risks; unifying cryopreservation, logistics, and storage early improves consistency, reduces operational gaps, and supports smoother progression into clinical phases.
-
In this paper, we present the foundation of an mRNA-LNP platform for encoding and expressing therapeutic antibodies in vivo, eliminating the need for costly and time-consuming manufacturing.
-
Lyophilization ensures product stability, extends shelf life, supports sensitive formulations, and simplifies storage and transport, making it a critical choice for modern drug development projects.
-
One main mRNA technology challenge is the formulation of delivery systems like lipid nanoparticles (LNPs). Learn about evading impurities in lipids, the future of mRNA-based genomic medicines, and more.
-
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.
-
Explore the details supporting LNP-mediated mRNA delivery, as well as the challenges facing mRNA based therapeutics in the future.
-
Define a process for your unique mRNA with this interactive guide to pDNA, mRNA, and LNP. Overcome challenges with solutions that can help you develop a next-generation production strategy.