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

Explore how Raman models and autosampling tools enable real-time bioprocess control, delivering richer data and automation. Learn how PAT technologies can help close data gaps and support smarter, more efficient biomanufacturing strategies.

mRNA-based therapeutics require comprehensive analytical testing to meet regulatory requirements. Optimize processes and ensure fast and reliable results as you bring your product to market.

This Advancing RNA Live clip dives into the biggest challenges in mRNA purification and the critical debate on where to focus investment. Here, our three mRNA PD experts argue for a holistic process development strategy, challenging the traditional wisdom of optimizing the upstream process at any cost.

NxGen Technology delivers a scalable means to perform the critical particle formation step in a nanomedicine development process.

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