MANUFACTURING ARTICLES
-
![Justified Risk-GettyImages-2232143649]( "What Oligo Manufacturing Risks Are We Underestimating?")
What Oligo Manufacturing Risks Are We Underestimating?Earlier this year, I attended the OPT Congress, where I had the great fortune of meeting consultant Marc Lemaitre. I recently sat down with Lemaitre for a follow-up interview to gauge some of the evolutions he’s been watching within the CMC landscape for oligo development. Here, he digs into the shifts in quality he’s noted, pointing out some of the potential pitfalls we may encounter in our manufacturing that could stand to impact the overall quality of our oligos.
-
![DNA Structure with molecule-GettyImages-2199475157]( "RNA Oligonucleotide Synthesis: How Advanced Manufacturing Technologies Are Accelerating Innovation")
RNA Oligonucleotide Synthesis: How Advanced Manufacturing Technologies Are Accelerating InnovationFrom a tech perspective, the manufacturing objective is shifting toward integrated process optimization. Automated reaction control, multivariate analytics, and more can connect molecular quality with operational performance.
-
![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.
MANUFACTURING VIDEOS
In this Advancing RNA Live clip, panelists Venkat Krishnamurthy and April Sena home in on the economic, molecular, and biological challenges complicating the transition to enzymatic ligation today.
Is enzymatic ligation a futuristic dream or a current commercial reality? In this segment, industry experts Claire MacCleod and Jill Caswell explore how the sector has moved past the proof-of-concept stage into early commercialization and what this looks like/means for early adopters today.
In this Bioprocess Online Live panel discussion, we talk about where the greatest sources of variability are in our downstream processes and how companies should be approaching the question of “how pure is pure enough?"
In this segment of the Bioprocess Online Live event mRNA Manufacturing: Bright Future, Big Challenges, we get to know leaders at three organizations bringing mRNA technology to bear in a variety of prophylactic and therapeutic capacities. Tune in and get to know Roberta Duncan, VP of the mRNA program at Seqirus; Duke Human Vaccine Institute Associate Director of Upstream and Downstream Process Development Jason Dickens, Ph.D.; and Jin Zhou, Executive Director of Process Development for mRNA and Protein Biologics at Ultragenyx.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![GettyImages-1076055404 chromatography, purification]( "The Secret To Pure Oligos: Why Anion Exchange Chromatography Rules At Scale")
Discover how anion exchange chromatography delivers high loading capacity and clinical-grade purity while addressing common scale-up challenges like aggregation and equipment longevity.
-
![GettyImages-2158862132-vials-robotic-arm-filling-liquid-handling-lab]( "Aseptic Process Design And Simulation Under Annex 1 Guidelines")
Gain insight into how Annex 1 reshapes aseptic process validation, as well as into risk reduction by design and why isolators are redefining modern sterile manufacturing standards.
-
![lab virtual science biologic bioprocess 450x300]( "5 Biggest Trends Of Oligonucleotide Manufacturing In 2022")
The rapidly growing market for Oligonucleotide manufacturing represents an opportunity for investors and pharma companies that wish to produce novel pharmaceutical products and therapies.
-
![Pellicon]( "Achieve Higher Targeted Concentrations")
Single-pass TFF streamlines downstream processing by reducing footprint, shear exposure, and hold-up volumes. Learn how this approach is advancing efficiency across therapeutic and vaccine production.
-
![GettyImages-517743436-plasmid-dna-development-lab]( "mRNA Manufacturing Workflow: Get To Clinic And Market Faster")
Explore each intertwined step in the mRNA manufacturing process and how a flexible approach can get your mRNA product to clinic and market faster.
-
![GettyImages-970394878-genetic-engineering-gene-editing-dna]( "Genome Editing Using mRNA-Lipid Nanoparticles For CAR T Cell Therapy")
Gene delivery platforms must support a diversity of genetic engineering strategies for genomic medicine development. Learn how lipid nanoparticles can accelerate development from discovery to scale-up.
-
![mRNA GettyImages-1356994684]( "Best Practices For Analysis Of IVT mRNA")
Discover how an automated capillary electrophoresis system provides robust and precise integrity, concentration, and size analysis for IVT mRNA.
