MANUFACTURING ARTICLES
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![Future-GettyImages-834713748]( "Antibody–Oligonucleotide Conjugates, Part 4: Regulatory Considerations And Future Directions")
Antibody–Oligonucleotide Conjugates, Part 4: Regulatory Considerations And Future DirectionsThis last article of the author's series on AOCs reveals regulatory perspective, analytical opportunities, the emergence of molecular quality by design, and the CMC challenges to address with future work.
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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.
MANUFACTURING VIDEOS
Discover strategies to optimize mRNA manufacturing, improve yield and full-length products, and enable scalable production of mRNA and saRNA therapies.
Explore how next-gen technologies, from mRNA platforms to digital tools, are transforming vaccine manufacturing to make it more sustainable, flexible, and accessible.
Experts from this Advancing RNA Live panel discuss the results from a poll question revealing the top three areas RNA industry experts would be most interested in seeing additional mRNA-specific guidance from regulatory agencies.
Gain an understanding of how an advanced nuclease portfolio is designed to support CRISPR-based cell and gene therapy development, providing scientists with the best solutions for therapeutic success.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1363605023-technician-equipment-technology-cleanroom]( "A Shift Towards Biofluorescent Particle Counters In Manufacturing")
Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.
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![GettyImages-1297146235-dna]( "Review Of mRNA Vaccines & Therapeutics Manufacturing Challenges: Plasmid DNA Manufacturing")
This review suggests technical remedial options for the production of pDNA and focuses on mRNA synthesis, purification, and encapsulation.
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![Why You Need Spare Parts On Hand For Pharma And Lab Equipment]( "Why You Need Spare Parts On Hand For Pharma And Lab Equipment")
Advanced spare parts planning can reduce downtime. Learn why precise component specifications matter and how seemingly identical parts can differ significantly in quality, performance, and failure risk.
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![GettyImages-618725044 lab, tablet, teamwork]( "Starting Smart: Building Early CGT Supply Chains")
Discover how building a scalable, compliant supply chain can set your CGT program up for long-term success and avoid risks that could derail progress down the line.
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![GettyImages-1648451263 Scientist Holding Tray Of Medical Samples In Lab]( "Continuous Nanoparticle Manufacturing For Gene Editing Delivery")
Messenger RNA-LNPs are a promising strategy for delivering gene-editing components. Learn how a continuous manufacturing platform can address the scalability and reproducibility challenges of this process.
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![Scientist lab cell and gene dna GettyImages-1305079941]( "Ultra-Sensitive Assay For Anti-Sense Oligonucleotide Quantification")
Learn about a new level in sensitivity for challenging analytes in matrix that opens doors for accurate bioanalysis and metabolism studies with specificity not achievable with orthogonal methods.
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![GettyImages-96310150-microfluidics.jpg]( "Getting Genomic Medicines Ready For Prime Time")
Explore the benefits of building a manufacturing process early, how research into LNPs in nucleic acid therapeutics will contribute to the development of future drugs, and more.
