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
Gain insight into the Return on Invested Capital (ROIC) advantages of an automated manufacturing facility and its correlation to the digital maturity of your operation.
Once you know what disease gene you want to target, you can very rapidly find the sequence of the molecule you want to use as the drug substance, and essentially print it out, go to a supplier or print it out on a machine.
The Mobius® MIX single-use mixing systems delivers advanced technology to make and purify plasmid DNA and mRNA.
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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![mRNA GettyImages-1356994684]( "Freezing mRNA: Best Practice")
By following some of the best practices in freezing mRNA, you can effectively balance product quality, cost-effectiveness, process safety, and efficiency.
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![Getty Images-823447656-vector-viral-lab-AAV-cell-development]( "CAR T Set The Pace So All Can Win The Cell Therapy Race")
Gain insight into the modest origins of cell therapy manufacturing and how this history has paved the way for future advancements from Bill Shingleton, R&D Leader at Cytiva.
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![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.
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![Cytiva-602047-5. Changing the Status Quo]( "Changing The Status Quo Of Vaccine Production")
Learn how the mRNA technology behind COVID-19 vaccines is poised to disrupt the status quo to improve global vaccine manufacturing capabilities.
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![MilliporeSigma]( "Next-Gen Bioprocess Monitoring: Smart Data Management And Analysis")
A new platform that includes digital technologies/data management, process analytical technologies and intensified processing will drive next generation bioprocessing.
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![GettyImages-1319439243-dna-gene-therapy-helix]( "Genomic Medicine Demands Manufacturing Innovation")
The promise of novel therapeutic modalities can only be realized when effective science is paired with efficient manufacturing to provide cost-effective therapies to patients in need.
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![GettyImages-183281520-plastic resins-polymer]( "Solvent-Free Purification Of D84-mer Oligonucleotide Using Capto™ PlasmidSelect Resin")
Discover a solvent-free process using Capto PlasmidSelect and Capto Q ImpRes resins. They enable high-purity, scalable purification of long oligonucleotides, achieving more than 95% of full-length product purity.
