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
In this segment of the BioProcess Online Live event CMC, SCALE UP, & THE ROAD TO mRNA REGULATORY APPROVAL, panelists Akhilesh Bhambhani, Sr. Director, Biologics Drug Product Development at Ultragenyx Pharmaceuticals and Roberta Duncan, VP and mRNA Program Lead at Seqirus share early learnings on the regulatory path.
In this video, Russell Johnson, VP Formulation Research for RVAC Medicines, and Aalok Shah, Director of Formulation & Drug Delivery for Strand Therapeutics, outline several examples of foundational research that could provide insights into how we attain more specific cellular uptake of LNPs.
Advancing RNA Live panelists Max De Long, Venkat Krishnamurthy and April Sena address two audience questions about the number/length of fragments for enzymatic ligation of gRNA.
NxGen™ microfluidic technology enables controlled and precise assembly of high-quality, uniform LNPs, ensuring reproducible scale-up of RNA-LNPs while maximizing drug loading and particle quality.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-506999858-scientists-cell-culture-lab-development]( "Optimization And Scale-Up Of A Plasmid DNA Production Process")
Optimizing pDNA production in E. coli requires strategic media selection and scale-up planning. Explore a study that identifies ideal conditions for high-yield manufacturing.
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![BioSpring Waters Inc]( "Learn How Compliance-Ready LC-MS Workflows for Oligonucleotides Can Expand your Analytical Services Portfolio")
CMO invests in solution to ensure data integrity and meet regulatory requirements as they expand their oligonucleotide manufacturing and analysis services.
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![GettyImages-1793747580-DNA-double-helix-AI]( "Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer")
Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency and innovation in bioprocessing workflows.
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![Handshaking-GettyImages-537252274]( "Communication And Transparency In Secondary Supply Qualification")
What should you look for when searching for the right vendor to help you maintain security of raw materials and how can you establish communication that builds confidence?
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![MRNA Technology-GettyImages-1366661187]( "Developing An mRNA-Encoded Antibody Platform To Accelerate Therapies To Clinic")
In this paper, we present the foundation of an mRNA-LNP platform for encoding and expressing therapeutic antibodies in vivo, eliminating the need for costly and time-consuming manufacturing.
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![Sartorius]( "Increasing Productivity Of pDNA DSP Using Sample Displacement Chromatography")
Here, two distinct polishing processes using monoliths are compared: bind-elute (BE) and the more recently developed sample displacement purification (SDP).
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![iStock-909908830]( "Navigating The Regulatory Maze: Fundamentals For Drug Development")
Learn about key regulatory concepts and ways to accelerate and reduce risk throughout the drug development journey.
