MANUFACTURING ARTICLES
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![fundamental comparison metaphor or analogy-GettyImages-2191773530]( "Comparing Advanced Modality Needs, Part 1: Manufacturing")
Comparing Advanced Modality Needs, Part 1: ManufacturingADCs, AOCs, ATMPs, cell and gene therapies, and oligonucleotide therapeutics represent distinct but interconnected approaches to precision medicine. Let's take a closer look at their manufacturing needs.
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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.
MANUFACTURING VIDEOS
Dive into this overview of vaccine development and learn how to overcome some key challenges with Precision NanoSystems Inc.'s field application scientist, Dr. Ian Villamagna.
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.
Max De Long, April Sena, and Venkat Krishnamurthy share their perspectives on the current “health” of CDMO SPOS and enzymatic ligation platforms, while also highlighting the “red flags” to look out for when taking stock of a CDMOs capabilities.
Multiple steps in the mRNA manufacturing process can appear more complex than they have to be. Learn how to simplify your approach and produce the best possible mRNA vaccines and therapeutics.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Quality-GettyImages-1360733079]( "Understanding The Hidden Value Of Quality")
Costs of poor quality (COPQ) cannot be overstated. Review the statistics that prove how costly it can be to avoid resolving quality issues in your processes and supply chain.
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![GettyImages-1293772880-Lab-Science-Research-Scientist-Discovery-Development]( "From Data To Decisions: Accelerating Your mRNA Drug Development With Analytics")
To stay ahead in the competitive landscape of mRNA development, adopt a comprehensive QC strategy today and begin conducting meaningful tests to ensure the quality of your test articles.
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![GettyImages-2215842270 lab]( "Charged For Action: The Hidden Secrets Of AEX Oligonucleotide Analysis")
Understanding how to fine-tune pH and ionic strength allows for the detection of truncated sequences and single-nucleotide variants, turning complex purification challenges into reproducible data.
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![iStock-879831370-plasmid-lab-cell]( "Pre-Banking And Avoiding Manufacturing Challenges For GMP Plasmids Containing Unstable Sequence Regions")
Ensuring consistent replication and proper retention of plasmid DNA sequence is vital to the economics and efficiency in generating starting materials used for production of AAV delivered gene therapy and mRNA vaccines and therapeutics.
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![GettyImages-2196950181-factory-scientists-laboratory-tablet-training]( "Building Better CDMO Supply Chain Readiness")
As advanced therapies grow more complex, CDMOs must move beyond fragmented logistics and embrace integrated supply chain partnerships to ensure scalability, compliance, and long-term success.
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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.
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![Molecule mRNA-GettyImages-1428646288]( "Optimizing mRNA For Success: A Guide To Enhanced Stability, Delivery, And Efficacy")
RNA offers exciting potential for vaccines, gene therapies, and personalized medicine, but challenges related to stability, delivery, and manufacturing persist.
