MANUFACTURING ARTICLES
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![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.
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![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.
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![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.”
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![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.
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![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.
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![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
This webinar explores mitigating the risk of product loss, and production delays, as well as the critical role rapid sterility testing plays in ensuring the quality and safety of cell therapy products.
Accelerate your path to the clinic with an integrated, risk-based cell banking strategy that delivers speed, quality, and regulatory confidence at every stage.
Learn about the key aspects of aseptic sampling, appropriate methods and circumstances to perform sampling, and the impact a platform and sample containers can have on assay results and process dynamics.
TFF Pharmaceuticals’ Kayla Hannon and University of Sheffield’s Dr. Zoltán Kis discuss the cost and capacity implications of therapeutic demand surges in this Surge Manufacturing for Biopharma Resilience segment.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![DNA strand virus-GettyImages-1755616400]( "The Future Of mRNA For Cancer Treatment")
As additional mRNA-based cancer immunotherapies vaccines enter clinical development, operational and supply chain challenges must be addressed to reduce turnaround times and COGS.
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![Molecule mRNA-GettyImages-1428646288]( "Digital Solutions Advance Your mRNA Manufacturing Workflow")
Explore the advantages of paperless manufacturing, the importance of incorporating a digital strategy early in the process, and how digital solutions for mRNA manufacturing can help enhance production.
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![GettyImages-1371707479-lab-mask-team-partnership]( "mRNA/saRNA Manufacturing RNA Program Development & Support")
Venkata Indurthi, Ph.D., shares his knowledge and experience with manufacturing RNA, including key upstream and downstream considerations that go into process development for RNA drug substance manufacturing.
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![GettyImages-1295693748-mRNA-strand]( "Analyzing Poly(A) Tails Of In Vitro Transcribed RNA")
Find out how to achieve reliable IVT mRNA quality. Learn the best practices for precise analysis, including proper sample prep and system optimization for high-resolution results.
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![Scientists working in lab-GettyImages-542935478]( "Screening T7 Polymerases To Optimize xRNA Yield And Quality")
Discover how the evolution of T7 polymerase is optimizing in vitro transcription for RNA therapeutics. Learn to balance performance, cost, and supply to make smart choices for your xRNA manufacturing.
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![mRNA iStock-1287178753]( "Manufacturing Strategies For mRNA Vaccines And Therapeutics")
mRNA has emerged as a promising modality offering a great deal of versatility for a wide range of therapeutics and vaccines with its use of non-viral delivery systems.
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![GettyImages-1326811027-lab]( "New To mRNA Manufacturing? Considerations For Starting")
Explore considerations for starting mRNA manufacturing related to the following topics: DNA template, mRNA product - IVT, mRNA product - purification, LNP encapsulation, and fill-finish.
