ANALYTICAL/QUALITY ARTICLES

  • 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.

  • The "Middle Ground" Advantage: Why Alnylam Is Betting Big On Chemoenzymatic Ligation

    Though conversations are picking up around this hybrid approach, we aren’t exactly known as an industry that embraces risk no-holds barred. While there are a handful of manufacturers and CDMOs who are embracing the hybrid model today, there are many more that are likely to hold out for the next-next gen approach: Fully enzymatic oligo production. However, as Alynlam’s CTO and Chief Quality Officer Tim Maines argued, embarking into the “middle ground” of enzymatic ligation is essential for garnering the step-by-step learnings needed to help us unlock even bigger manufacturing wins in the future. 

ANALYTICAL/QUALITY VIDEOS

Explore how next-gen technologies, from mRNA platforms to digital tools, are transforming vaccine manufacturing to make it more sustainable, flexible, and accessible.

Advancing biologics requires confidence in safety, quality, and compliance. Learn how integrated analytical and biosafety testing, backed by decades of expertise, helps reduce risk.

What is Bio-Layer Interferometry (BLI)? Watch to learn about BLI and the advantages of utilizing a proven BLI platform.

We all know that plasmid quality is foundational in dictating the quality of the final mRNA drug substance. In this clip homing in on upstream process considerations, speakers Stu Sundseth (Tune Therapeutics), Marc Wolfgang (Sail Biomedicines), and Christian Dohmen (Ethris) outline some of the most important CQAs for plasmids and the impact they can have on the resulting quality of the mRNA drug substance for linear mRNA. 

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS