ANALYTICAL/QUALITY ARTICLES

  • 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. 

  • The Monster Under The Bed: Defining Potency in the mRNA Space

    During the CASSS mRNA Symposium last spring, a seemingly simple, straightforward question was raised: How are we defining and measuring our product’s potency? But as we already know, this is far from a straightforward question — and, dear reader, based on the resulting discussion amongst regulators and panel members, it became clear we have a lot of different definitions on what potency even is in the mRNA space.

  • Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle Control

    Oligonucleotide therapeutics have rapidly advanced into late-stage and commercial development, shifting regulatory focus toward the maturity of manufacturing and supply chain control rather than therapeutic novelty. Regulatory success now depends on how effectively sponsors translate innovative chemistries into well-characterized, scalable, and sustainable materials and processes.

  • The mRNA Supply Chain Revolution: Materials, Methods, And Momentum

    mRNA innovation now hinges as much on manufacturing materials as on molecular design, with novel inputs shaping performance, cost, and scalability. As these less-mature materials move rapidly into production, strategic material selection and supplier alignment are becoming critical to manufacturing resilience and long-term success.

  • In Vivo's Biggest Threat — Comparison To Old Models

    In vivo CAR-T is not simply ex vivo without a manufacturing step. It is a different modality that relies on biological systems to regulate outcomes.

ANALYTICAL/QUALITY VIDEOS

Explore how preserving spatial molecular information and leveraging AI-driven spatial-omics can transform treatment prediction, patient stratification, and personalized medicine.

Featured speakers for the "Got Raw Materials? The State Of The mRNA Supply Chain" event share how they are working to deepen their partnerships today.

The Advancing RNA Live panelists share several inconsistencies they’ve encountered working with global regulators, as well as on which aspects they’re seeing regulatory agencies applying greater scrutiny in mRNA development today.

In this clip, Advancing RNA LIVE, panelists, share their perspectives on how advancements in RNA analytical development are complementing and informing process development efforts for linear mRNA.

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS