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
Is the future of RNA manufacturing fully enzymatic? In this Advancing RNA Live clip, panelists Claire MacCleod and Jill Caswell unpack why the "hybrid" chemoenzymatic approach is an essential bridge to an enzymatic future for siRNA production.
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.
In this Advancing RNA Live clip, Sanofi’s Sumit Luthra highlights the learnings we’ve made to-date about how our processes — both in terms of unit operations and process conditions — inform our LNP composition/heterogeneity.
It goes without saying that achieving cell-specific delivery is the most often discussed challenge facing the RNA-LNP field near- and long-term. However, as these three LNP experts share in this Advancing RNA Live clip, they have a whole list of additional R&D and CMC priorities we must address/accomplish to improve RNA-LNPs’ efficacy in personalized and gene therapy approaches.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1256323645 lab, biotech]( "Genetic Engineering Medium Aiding The Transfection Of MSCs With siRNA")
A newly developed genetic engineering medium is fueling the development of cell- and extracellular vesicle-based therapies.
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![PCR Plate GettyImages-867159726]( "Meeting Regulatory Requirements With Confidence")
An outbreak of mycoplasma can halt a biopharmaceutical facility's production for months. Explore the impact of mycoplasma contamination and the most accurate and sensitive way to detect it.
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![cell-gene-therapy-GettyImages-2157300524]( "Safe, Scalable And GMP-Ready DNA")
Cell‑free synthetic DNA provides a scalable, safer alternative to plasmids by eliminating bacterial risks, simplifying quality control, and enabling complex sequences under GMP‑aligned conditions.
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![GettyImages-1209614664-cell-gene-dna-research-development]( "Quantification Of Large Oligonucleotides Using High Resolution MS/MS")
Explore how to achieve sensitive, high-resolution analysis of large oligonucleotides, with the opportunity to perform both qualitative and quantitative analysis in a single run.
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![GE-fasttrak]( "Optimizing Process Efficiency In Upstream Manufacturing")
Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency — a key goal for biopharma production.
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![Vaccine Manufacturing GettyImages-1384850913]( "Modeling The Economics Of Vaccine Manufacturing")
Here, we describe the use of a custom-designed cost model to explore the economics of vaccine manufacturing when using different modalities.
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![scientist iStock-1166567091]( "mRNA Transfection Reagent Enhances Non-Viral Gene Delivery To Stem Cells")
Researchers demonstrate a delivery mechanism that is a simple and ready-to-use transfection reagent that leads to outstanding transfection efficiencies in known hard-to-transfect stem cells.
