MANUFACTURING ARTICLES
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![Action Plan-GettyImages-2249288072]( "Antibody–Oligonucleotide Conjugates, Part 2: Manufacturing")
Antibody–Oligonucleotide Conjugates, Part 2: ManufacturingLet's delve into manufacturing strategy, conjugation chemistry, process development and scale-up, and purification: the central manufacturing challenge.
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![Financial security, wealth protection, money insurance-GettyImages-2288391875]( "Protecting The Platform: Trade Secret Protection For RNA Biotech Companies")
Protecting The Platform: Trade Secret Protection For RNA Biotech CompaniesAs RNA therapeutics grow more complex and collaborative, trade secrets are becoming an increasingly important part of protecting valuable platform innovation.
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![creativity, innovation-GettyImages-2209122228]( "Engineering RNA Agonists For Systemic Immunity Without Systemic Toxicity")
Engineering RNA Agonists For Systemic Immunity Without Systemic ToxicityKrieg believes the answer lies in a deeper understanding of innate immune biology and the design of RNA/DNA hybrid mimics of viral RNA and DNA that are detected by innate immune receptors.
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![economy law of supply and demand-GettyImages-1263079550]( "Is mRNA Manufacturing Overbuilt?")
Is mRNA Manufacturing Overbuilt?mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.
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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.
MANUFACTURING VIDEOS
In this Bioprocess Online Live panel discussion, we identify the manufacturing-centric efficiencies taking shape today that could encourage us to think differently about the mRNA manufacturing paradigm in the future.
In this Bioprocess Online Live panel discussion explore how two industry experts encourage their CMC and R&D teams to work more closely together to ensure a streamlined transition of a molecule from R&D to process development.
Single-pass tangential flow filtration effectively concentrates mRNA-LNPs and removes ethanol while maintaining quality. See how this approach produced LNPs with 4.2-fold higher in vitro potency.
Chief Scientific Officer and Founder Christian Cobaugh, Ph.D., examines the critical quality attributes of mRNA and LNPs that are pivotal to enhancing drug efficacy and safety.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1470034194-magnifying-glass-charts-calculator]( "Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators")
Are robotic gloveless isolators the key to smarter, safer, scalable solutions? Discover how they can revolutionize aseptic filling by reducing contamination, minimizing waste, and enhancing manufacturing flexibility.
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![Virus and Genes iStock-843037718]( "Downstream Process For Gene Therapy, Plasmid-DNA Vaccine Development")
A guide to plasmid DNA downstream process development including clarification, TFF, chromatography, and sterile filtration unit operations.
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![iStock-1296757866-research-lab-flask-microscope]( "Understanding Sterile Filtration And Importance Of Prefiltration")
Learn more on the importance of sterile filtration and how sterile filters are validated by the manufacturer and review the process and value of selecting the best prefilter to improve final sterile filtration performance.
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![GettyImages-2148124393 DNA]( "A Risk-Based Approach To Plasmid DNA And mRNA Process Development")
Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.
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![GettyImages-542935478-lab-development-research]( "Oligo-Ready")
The benefits of continuous flow manufacturing are significant and numerous and those benefits grow with each technological breakthrough and methodological advance.
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![1100x600 real ebook image Cytiva white background]( "Aseptic Filling By Design: Shaping The Future Of Drug Manufacturing")
Modern therapies demand higher sterility assurance and flexible operations. Discover how advanced contamination control, barrier systems, and automation strengthen quality and support faster delivery.
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![Molecular biology, mRNA strands, genetics-GettyImages-2198118160]( "Transitioning mRNA Production To cGMP Requires Early Process Engagement")
Early choices in capping strategy, IVT conditions, raw materials, and downstream design shape yield, cost, and quality in mRNA manufacturing, and can determine whether a cGMP campaign succeeds.
