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
Featured speakers for the "Got Raw Materials? The State Of The mRNA Supply Chain" event share how they are working to deepen their partnerships today.
mRNA therapeutics are applicable to cancer immunotherapies, infectious diseases, and other indications that require protein replacement therapy or antibodies.
In this Bioprocess Online Live panel discussion featuring John Stubenrauch, Ph.D., Chief Operations Officer at Nutcracker Therapeutics, and Hari Pujar, Ph.D., Chief Operating Officer at Tessera, explore the impact of and how to potentially mitigate issues posed by raw material variability.
Learn about method development considerations when selecting an appropriate ion-pairing agent and impurity analysis of dye-conjugated oligonucleotides.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![mRNA GettyImages-1356994684]( "Elevating mRNA Manufacturing Toward GMP-Readiness")
The mRNA Technology Transfer Program empowers LMICs with scalable vaccine production. Learn about a partnership that drives innovation in mRNA and sets a global blueprint for equitable health access.
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![GettyImages-1354923731-mRNA-discovery]( "End-To-End Solutions To Support Your mRNA Therapeutics Workflow")
Take a step-by-step review of the mRNA therapeutics journey and find out how you can meet the critical process, scale, quality and regulatory needs from development to commercialization.
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![Thermo Fisher - Peptones]( "The Value Of Peptones For Enhancing Biopharmaceutical Productivity")
Peptones, versatile media additives derived from various sources, offer numerous benefits for biopharmaceutical production.
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![GettyImages-1183908006 bioanalysis]( "5 Outdated Practices Holding Back Modern Bioanalysis")
Bioanalysis must replace outdated paper, manual processes, and disjointed systems with integrated, automated platforms for continuous validation, efficiency, compliance, and to support complex modern therapies.
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![Pellicon]( "Achieve Higher Targeted Concentrations")
Single-pass TFF streamlines downstream processing by reducing footprint, shear exposure, and hold-up volumes. Learn how this approach is advancing efficiency across therapeutic and vaccine production.
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![GettyImages-2270210340-lipid-nanoparticle-delivery-system]( "Extrahepatic Delivery Of mRNA-LNP To Spleen")
In vivo CAR-T approaches aim to reprogram T cells directly in the body using targeted lipid nanoparticles. Improved delivery to immune organs highlights new potential for scalable cell therapies.
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![bacterial colonies for pDNA cloning iStock-180342961]( "Comparison Of HIC Monolithic Support For Sample Displacement Chromatography Of pDNA")
Competing adsorption in sample displacement chromatography utilizes the chromatographic resin's binding capacity more efficiently and increases the chromatographic step's productivity. This application note investigates three monolithic chromatographic supports with different hydrophobicities regarding their applicability for sample displacement of pDNA. CIMac™ C4 HLD (butyl, high ligand density) as a commercial product and pyridine and histamine as custom immobilised columns are compared.
