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
Walk step-by-step instructions through how you can set up the Nova Benchtop System and make your first LNPs.
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.
In this clip, Advancing RNA Live panelist Venkat Krishnamurthy unpacks how solid-phase synthesis has been improving to overcome current challenges with gRNA production, while Max De Long and April Sena share their perspectives on the maturity of current CDMO platforms for enzymatic ligation of gRNA.
Explore best practices for developing a QC method for identification and impurity analysis of oligonucleotides, as well as tips on mitigating risk by using compliant instrumentation and software.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![viral clearance services]( "Choosing A CDMO That Can Grow With A Viral Program")
Viral modalities demand more from CDMO selection: relevant experience, rigorous tech transfer, analytical readiness, and a clear path to scale matter more than equipment alone.
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![GettyImages-1443323134-digital-binary-code-artifical-intelligence-robotic-hand]( "Digital Twins And Mechanistic Models For Optimized Bioprocessing")
Integrating AI and having a robust IT infrastructure is crucial for modernizing your processes. Discover how digital twins and mechanistic modeling are revolutionizing biomanufacturing, enhancing efficiency, and reducing costs.
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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.
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![GettyImages-515631085-cryopreservation-cryo-cold]( "Expand Trial Footprints Without Expanding Cryopreservation Risk")
Transitioning from fresh to frozen starting material stabilizes cell therapy inputs, but isolated workflows introduce risk. Integrated logistics safeguard quality as trial footprints expand.
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Here, a fast and efficient way to purify polyadenylated mRNA using affinity chromatography on the CIMmultus® Oligo dT column is presented.
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![Cytiva-602047-1. Accelerating the Development]( "Accelerating The Development And Scale-Up Of mRNA Vaccines")
Learn how downstream considerations can make the difference between success and failure on the path towards the commercialization of mRNA vaccines.
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![Genomic sequencing, molecular biology, and genetic data analysis-GettyImages-2153790378]( "The Paradigm Shift: From Scale-Up To Scale-Out In Genetic Medicine")
The shift from "scale-up" to "scale-out" in genetic medicine enhances production speed, revolutionizing pharmaceutical manufacturing and accelerating life-saving therapies for global patient populations.
