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
ALMAC expert Jill Caswell identifies the most overlooked challenges of working with ligase for the chemoenzymatic reaction, as well as the impact this is having today on enzyme engineering and purification.
Gain practical guidance for improving oligo quality, see how an advanced synthesis platform supports production, and explore a software interface designed to make daily operations more intuitive.
In this clip, Advancing RNA Live panelist Venkat Krishnamurthy unpacks how solid-phase synthesis has been improving to overcome current challenges with gRNA production, while Max De Long and April Sena share their perspectives on the maturity of current CDMO platforms for enzymatic ligation of gRNA.
In this video, Russell Johnson, VP Formulation Research for RVAC Medicines, and Aalok Shah, Director of Formulation & Drug Delivery, Strand Therapeutics, discuss what industry challenges should be top of mind for experts as it relates to the regulatory paradigm, toxicity/safety, and in vivo modeling.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![iStock-1051617224-automation]( "Accelerate GMP Certification With Annex 1-Compliant Aseptic Automation")
Rapid GMP certification is possible with Annex 1-aligned aseptic workflows that reduce contamination risks. Learn how advanced automation and isolator technologies help CDMOs meet regulatory demands.
-
![GettyImages-155373764-cryopreservation-cold-chain]( "Expanding Supply Chain Solutions With Vein-To-Vein Offerings")
Leveraging a partner experienced in controlled temperature GMP-compliant storage, secondary packaging/labeling, and kit production is critical to advance your CGT project to market.
-
![GettyImages-1090255620-lab-research-microscope-computer]( "When Is A New Biologic Ready For GMP Production?")
While there are differences by modality in DNA, RNA, and protein, find general recommendations on questions to prepare for and steps to consider when preparing to move to clinic.
-
![Bioprocess Pharma Vial GettyImages-1130423724]( "Talent Crossover: Extend Your Workforce Through Supplier Partnership")
Experts at Sartorius discuss the challenges complex molecules present to drug manufacturers today and the vital role suppliers play in fulfilling talent gaps for their customers.
-
![GettyImages-1418152314]( "Unpacking The Importance Of Lipid Nanoparticle Production Platforms")
Batch processing platforms for LNPs lack efficiency, appropriate controls, and yield optimization. Continuous manufacturing platforms may address some of those issues.
-
![Lipid nanoparticle mRNA vaccine-GettyImages-1418152448]( "Development Of LNP Formulations Using The KNAUER NanoScaler")
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.
-
![SA25-Aseptic-Filling-Workcell-interior-5]( "Standardization And Flexibility In Aseptic Filling")
Standardization and flexibility in aseptic filling were thought to be mutually exclusive. But what if there was a standardized system with flexibility built into the aseptic process, so you didn’t have to choose?
