MANUFACTURING ARTICLES
-
![money loss, spending, poor financial management-GettyImages-2224880481]( "What Baby KJ Taught Us About mRNA COGS")
What Baby KJ Taught Us About mRNA COGSHere, in part 2 of this three-part series, I share a few details that came to light about the COGS behind Baby KJ’s therapy production. Obviously, we know why it’s important to keep these figures in mind as we move forward; but I particularly liked Strauss’ reminder that it’s our job to “think systematically about how we’re going to create a safety net of sustainable, accessible product that can be widely distributed at an affordable cost.”
-
![intelligent technology interface, robot chat-GettyImages-2279572840]( "Analytical Platforms: The Foundation Of The Next Generation Of RNA Therapeutics")
Analytical Platforms: The Foundation Of The Next Generation Of RNA TherapeuticsRNA therapeutics are entering a new era where analytical platforms drive scalability, regulatory confidence, manufacturing flexibility, and the development of increasingly complex products.
-
![nucleic acid, DNA, RNA, purified protein-GettyImages-1350828873]( "A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA Products")
A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA ProductsNIST research introduces a gentle SEC method that separates dsRNA impurities from IVT mRNA by tweaking buffer pH, achieving 81.8% target recovery without transcript damage.
-
![Leukodystrophy Awareness Month-GettyImages-2166836167]( "The Preclinical Gauntlet: Securing Capital And Designing Regulatory Pathways For Ultra-Rare ASO Drugs (Pt. 2)")
The Preclinical Gauntlet: Securing Capital And Designing Regulatory Pathways For Ultra-Rare ASO Drugs (Pt. 2)SynaptixBio CEO Dan Williams explains why funding, regulatory strategy, toxicology, and disciplined execution — not just science — determine success in advancing ultra-rare ASO therapies.
-
![MacKay suspension bridge-GettyImages-2281791194]( "Bridging The Atlantic: A European Executive's Guide To Building A Successful U.S. RNA Business (Pt. 2)")
Bridging The Atlantic: A European Executive's Guide To Building A Successful U.S. RNA Business (Pt. 2)European RNA biotech leaders can accelerate U.S. success by aligning fundraising, partnerships, manufacturing, hiring, and regulatory strategy from day one.
-
![GettyImages-1494348289_lab microscope]( "The Delivery Challenge For In Vivo Cell Engineering")
The Delivery Challenge For In Vivo Cell EngineeringAs RNA therapies expand beyond the liver, delivery—not payload design—has become the defining challenge for precise, scalable in vivo cell engineering.
MANUFACTURING VIDEOS
We share our experience working with organizations as they adopt solutions for automated data acquisition, aggregation, visualizations, and statistical analysis.
Explore the evolving oligo therapeutic landscape while identifying common challenges of bringing production in‑house and the key factors that shape long‑term success for smoother scale‑up.
As a field, we’ve been aligned around CQAs for our mRNA drug substances. However, differences in translation between highly similar mRNAs (i.e., (same sequence, same design, different manufacturers) raises the question of whether we’re missing any QAs/CQAs. Here, Advancing RNA Live panelists Elaine Peters and Ilya Shestolapov share their take.
Discover how continuous manufacturing of nanoparticles can improve process efficiency, reduce costs, and increase the quality of the final drug product.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![Syringe and vaccine vial-GettyImages-1855924776]( "Future-Proofing mRNA Drug Manufacturing: The Value of Continuous Improvement")
With so many uncertainties permeating the mRNA market, this largely preclinical industry is still seeking answers on how to reach successful therapeutic development. Identifying optimizations, both sequence-dependent and otherwise, to enhance the manufacturing process is crucial for advancing mRNA product development, which holds vast potential to address a wide range of indications.
-
![MSglassvials]( "Supporting Complex Manufacturing For Liquid And Lyophilized Drug Products")
Aseptic fill and finish operations gain efficiency and precision with modular isolator technology, inline weight checks, and lyophilization, which are ideal for mRNA-LNPs and other sensitive modalities.
-
![Emergent BioSolutions]( "Aseptic Filling Solution Enhances Sterility Assurance for Pharma Manufacturer")
Emergent BioSolutions upgraded its Winnipeg site with the Cytiva SA25 aseptic filling workcell to improve sterility assurance, product flexibility, and regulatory compliance for CGT manufacturing.
-
![GettyImages-533059254-rna-dna-strand-light]( "Scalable, Sustainable Support For Next‑Gen Primer Systems")
Explore how an optimized solid‑support design enables higher synthesis scales, steadier pressures, and lower solvent use while preserving yield and purity across diverse oligonucleotide lengths.
-
![GettyImages-1298788278 drug manufacturing]( "Improving U.S. Drug Supply Stability Through Continuous Nanoparticle Processing")
Learn about a continuous manufacturing platform designed to help overcome challenges in domestic pharmaceutical production, including scale-up barriers and production variability.
-
![GettyImages-2098817477-vaccine-needle-syringe-gloved-hands-laboratory]( "mRNA Vaccines And Therapeutics: Current Trends And Perspectives")
Delve into the advancements and transformative impact of mRNA vaccine technology on modern medicine and explore how this technology is revolutionizing healthcare for the future and beyond.
-
![GettyImages-1793747580-DNA-double-helix-AI]( "Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer")
Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency and innovation in bioprocessing workflows.
