ANALYTICAL/QUALITY ARTICLES

  • 5 Key Questions On How To Accelerate mRNA Development

    Stakeholders are working to solve key mRNA manufacturing challenges, including how raw materials impact product quality and how to address scale up. Though existing analytical and manufacturing technologies may fall short for mRNA, investment in innovative techniques will help meet increasing demand for personalized therapeutics.

  • The RNA Ties That Bind: 3 Takeaways From The OPT Congress

    Here, I unpack three takeaways I had from the OPT Congress, each of which I’d argue are indicative of the interconnectedness across the genetic medicines field.

  • Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign

    The compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.

  • MicroRNA Therapeutics In Metabolic Liver Disease: Context-Driven Drug Discovery

    Realizing the therapeutic potential of miRNAs in liver disease requires confronting a problem the field has not fully reckoned with.

  • Inside Alnylam's Playbook For High Volume siRNA Production

    As one of the first companies to establish a chemoenzymatic ligation platform, Alnylam's Maines and Nechev are in the perfect position to espouse wisdom on the practical aspects and remaining challenges of implementing enzymatic ligation at a large scale. Here in this installment, Maines and Nechev outline what they’ve learned thus far about the science of enzymatic ligation, while also paying credence to the unknowns and existing barriers that, as a frontrunner, Alnylam will inevitably (but willingly) be tasked with facing in the future.

  • Proteomics Tools: A Resurrection

    For decades, the evolution of proteomics has lagged. Now, a resurrection is underway. New tools are dismantling limitations, signifying a maturation of systems biology.

ANALYTICAL/QUALITY VIDEOS

Discover how to integrate appropriate materials and tools for oligonucleotide handling, optimize DNA storage using dedicated fluoropolymer film, perform complex biochemical reactions in bags, and more.

Ensure your mRNA's stability and effectiveness post-transcription with advanced filtration and chromatography techniques to enhance purity and recovery, which delivers high-quality mRNA for superior therapeutics and vaccines.

Companies often underestimate the information required for IND submissions, particularly in a sector that’s as diverse as the mRNA sector. Here, former FDA reviewer Tiffany Lucas shares some of the missteps companies can make when first approaching the FDA with their IND. CureVac’s Ulrike Jägle furthers the discussion, offering a critical best practice she and her colleagues rely upon as well to streamline their regulatory interactions.

Is enzymatic ligation merely a "volume play"? In this segment, Advancing RNA Live speakers Claire McCleod and Jill Caswell challenge this belief, explaining the extent at which this paradigm shift also unlocks higher siRNA purity. 

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS