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
-
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.
-
Advance your lipid‑based programs with a CDMO partner equipped to deliver customized excipients, proven scale‑up expertise, and reliable support from early development through commercialization.
-
Learn about an innovative closed, single-use system and proprietary mixing technology aimed at improving reproducibility and reducing contamination risks in biopharma manufacturing.
-
Risk analysis and lane qualification show supply chains perform consistently, meeting regulatory expectations by demonstrating control, reducing variability, and ensuring reliable delivery.
-
Personalized cancer vaccines need fast, flexible manufacturing. Cell‑free synthetic DNA enables rapid, small‑batch mRNA production, supporting individualized therapies beyond plasmid‑based limits.
-
Effective template generation sets the tone for successful DNA and mRNA manufacturing, reducing risk and complexity early while supporting speed, consistency, and regulatory confidence across development and production workflows.
-
Learn more about issued guidelines on Critical Quality Attributes for IVT mRNA vaccines and biotherapeutics to focus on drug substance and LNP-encapsulated drug product assessment using an analyzer system.