Newsletter | December 6, 2023

12.06.23 -- New Developments In mRNA Vaccine Efficacy Show Promise

FEATURED EDITORIAL

New Developments In mRNA Vaccine Efficacy Show Promise

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.

Oh, Oligonucleotides! Everybody Wants In

“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.

FDA Sets Recommendations For Predicting Nitrosamine Impurities

The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.

INDUSTRY INSIGHTS

Leveraging Single-Use Technology For mRNA-LNP Drug Manufacturing

Single-use technology is vital for ensuring the quality and expedited market entry of genomic medicines. Discover how LNP technology is paving the way for a new era of personalized, precise medicine.

mRNA: How To Build A Custom Program Using CDMO Services

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.

Ready To Amplify Plasmid (pDNA) In Bacteria?

Explore how to use and amplify pDNA, from the development of recombinant proteins and viral vectors to advanced biotherapeutics such as mRNA vaccines.

Analyzing COVID-19 Vaccine Purity Using LC-MS Technologies

Learn why process-related impurities are a concern in vaccines and present results and learnings from LC-MS analyses of several mRNA- and protein-based vaccines for COVID-19.

Reduce The Environmental Footprint Of Oligonucleotides

Yuki Shinohara from Ajinomoto Bio-Pharma Services answers attendee questions from a recent webinar about sustainability concerns surrounding oligonucleotide manufacturing.

Addressing Industry Challenges In mRNA Product Commercialization

While the speed of production and flexibility of mRNA are appealing, several industry challenges must still be addressed to realize the full potential and further expand its use.

mRNA/saRNA Manufacturing RNA Analytics And Testing

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.

Lipid Nanoparticle Compositional Analysis By UHPLC-CAD

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.