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By Olivier Laczka, Ph.D., CSO, Noxopharm | Significant caveats with the current base modification approach for mRNA vaccines still remain and need to be addressed. This article looks at activation of innate immunity, overcoming the limitations of pseudouridine, novel 3-base oligonucleotides, and more. |
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By Louis Garguilo, chief editor, Outsourced Pharma | “We’re working on oligonucleotides,” says the bubbling biotech. “We can do oligos!” cries the eager CDMO. So, it’s a deal? “Hang on,” says Tony Sampognaro, director, CMC project management, at oligo-focused Stoke Therapeutics. |
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By D. Farquhar and R. Lewis, Hyman, Phelps & McNamara | The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities. |
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| mRNA: How To Build A Custom Program Using CDMO Services | Article | By Dieter Kramer and Christoph Winterhalter, AGC Biologics | Development of RNA-based therapies sits at the cutting edge of vaccine and oncology innovation, in addition to holding promise in dozens of other therapeutic areas. |
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| Ready To Amplify Plasmid (pDNA) In Bacteria? | Article | By Valentina Haag, INFORS HT | Explore how to use and amplify pDNA, from the development of recombinant proteins and viral vectors to advanced biotherapeutics such as mRNA vaccines. |
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| mRNA/saRNA Manufacturing RNA Analytics And Testing | Q&A | Aldevron | Venkata Indurthi, Ph.D., shares his knowledge and experience with manufacturing RNA, including key downstream considerations for characterization and purity, and how to achieve more efficient dosing. |
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| Lipid Nanoparticle Compositional Analysis By UHPLC-CAD | Application Note | MilliporeSigma Biosafety Testing Services | Explore results generated from an internal study using a proprietary mRNA-LNP formulation and UHPLC-CAD, a powerful technique for the analysis of compounds that do not contain chromophores. |
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