RNA Analytical/Quality Articles

  1. Top 5 mRNA/RNA Developments of 2024 (Part 1) 12/23/2024

    In the past few weeks, I’ve shared two articles outlining several RNA executives’ thoughts on advancements from 2024, as well as the challenges facing us in 2025. But why stop there? Below in the first of this two-part article, I share the first two of my five overarching observations from 2024.

  2. "The Ghost Of mRNA's Future": 2025 Outlook From RNA Leaders 12/17/2024

    As the Charles Dickens fans among us already know, there is still one pretty important “ghost” that has yet to be channeled on this “hallowed” page, and that’s the “Ghost of mRNA/RNA Innovations Yet To Come.” (Yes. That’s a thing.) Here, I share several future-facing “visions” from the conversations I had with five RNA leaders.

  3. Is Your CDMO Using These AI-Driven Solutions In CMC For Oligos And Peptides? 12/10/2024

    Oligonucleotides and peptides require precise, scalable, and compliant production. CDMOs are integrating AI-driven technologies to answer the call. Many of these technologies are notable for specific needs.

  4. RNase Control: An Overview With Market Trends 12/2/2024

    This article shares an overview of ribonuclease (RNase) control and some associated macro market research.

  5. Commercializing mRNA: 3 "Action Items" To Turn Promising Science Into Real-World Impact 11/26/2024

    The recent Alliance for mRNA Medicines’ inaugural Ascent conference provided us with a lot of great updates on the mRNA industry’s progress. But throughout each of these specific conversations, there was a shared underlying question: How can we become a less esoteric industry?

  6. RNA Therapeutics: Navigating The "Holy Trinity" Of Structure, Process, & Biology 11/19/2024

    During our hour-long conversation, Sagaert and I covered a lot of ground on the current state of the industry. But given his background in quality, it shouldn’t come as a surprise that our conversation ultimately gravitated back to some of the biggest questions we currently have and need to answer about our product’s structure and function — and how to adequately demonstrate this critical knowledge to regulators.

  7. CMC Strategies With CDMOs: Ensuring CQAs For Oligos And Peptides 11/18/2024

    Developing a practical chemistry, manufacturing, and controls (CMC) strategy for oligonucleotides and peptides demands a shift in approach in terms of the way you collaborate with your CDMO.

  8. Emerging Partnership Trends In Oligo-Based Medicines 11/6/2024

    The oligonucleotides sector is quickly evolving and seeing more industry partnerships than ever before. We caught up with DeciBio's Carl Schoellhammer and Phillip Leclair for their analysis.

  9. EMA Issues Draft Guideline On The Development And Manufacture Of Oligonucleotides 9/26/2024

    The EMA recently issued a draft guidance, Guideline on the Development and Manufacture of Oligonucleotides. It includes requirements and considerations related to conjugation, active substance in solution, and more. The consultation period ends Jan. 31, 2025.

  10. Strategies To Address FDA CMC Trends For mRNA Therapies 9/24/2024

    A CMC consultant shares learnings from recent interactions with FDA regulators. The discussion primarily addresses prophylactic mRNA-LNP vaccines, though many considerations apply equally to therapeutic mRNA-LNP applications.