FORMULATION ARTICLES
-
Oligonucleotide Therapeutics At Scale: Bottlenecks, Breakthroughs, And What Comes Next
Oligonucleotide therapies have proven clinical value, but scaling beyond rare disease remains hard. William Soliman, Ph.D., BCMAS, breaks down the manufacturing, delivery, and CMC realities shaping what comes next.
-
In Vivo LNP-Engineered Cytokine-Armored CAR Cells For Solid Tumors
By injecting lipid-based nanoparticles encapsulating mRNA and encoding the CAR directly into the bloodstream, developers can effectively reprogram the patient's own immune cells in situ.
-
Powering Cell Therapies With RNA: A New Code For Engineered Immunity
RNA is redefining cell therapy engineering—enabling transient, programmable control of immune and stem cells while simplifying manufacturing, improving safety, and accelerating scalable, virus-free workflows.
-
Why RNA Tech Transfer Is So Hard — And How the Field Can Fix It
A closer look at why RNA tech transfer remains one of the field’s toughest bottlenecks — and the practical steps developers and CDMOs can take to finally streamline the path to GMP.
-
Four Reasons You Should Choose Lyophilization for Your Next Project
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.
-
Making Personalized Cancer Vaccines Reality: The Manufacturing Challenge Ahead
Personalized cancer vaccines are becoming feasible, but scaling fast, affordable, data-driven manufacturing is the central challenge to bringing these individualized therapies to more patients.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.
-
Explore results generated from an internal study using a proprietary mRNA-LNP formulation and UHPLC-CAD, a powerful technique for the analysis of compounds that do not contain chromophores.
-
Explore the benefits of building a manufacturing process early, how research into LNPs in nucleic acid therapeutics will contribute to the development of future drugs, 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.
-
Industry experts discuss current and future trends, formulating successful lipid compositions and navigating the constantly evolving genomic medicine landscape.
-
Technical summaries and detailed protocols for purity testing, sizing, sequencing and expression analysis of oligonucleotide-based active agents as well as protein and lipid-based delivery systems.
-
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.