RNA Analytical/Quality Articles

  1. The mRNA Industry's Three Wishes: Can CDMOs Play The "Genie?" 3/5/2025

    During the panel discussion last November, three CDMO execs shared the biggest scientific, regulatory, and technological complexities barring a “magical” solution to each biotech’s wishes. However, as each of the AMM panelists pointed out, there are short- and long-term technological innovations in the works that will be essential in advancing the manufacturing infrastructure for mRNA therapeutics in all their shapes, forms, and scales. 

  2. Understanding The New U.K. MHRA 'Draft Guideline On Individualised mRNA Cancer Immunotherapies' 3/5/2025

    The U.K.'s MHRA has released a new draft guideline outlining best practices for drug product design, CMC, and manufacturing of mRNA cancer immunotherapies using LNP delivery systems. The public comment period ends March 31.

  3. 10 Ways To Speed Up CMC In Early-Stage Drug Product Development 2/21/2025

    The inherent complexity of living cell-based products, vector-based gene therapies, and highly sensitive analytical methods demands robust change management strategies.

  4. What Do We (Really) Know About DNA Quality For In Vitro Transcription? 2/19/2025

    Gene therapies and nucleic acid medicines are dependent upon a starting DNA template that defines the protein or antigen. The sequence of this template DNA being correct is critical.

  5. Cultivating A Thriving mRNA Ecosystem: Key Initiatives & Future Directions 2/13/2025

    Overall, I felt that the following initiatives/talking points were demonstrative of the types of creativity and symbiosis that we will need much more of in the near and long-term to foster a healthy and fruitful RNA ecosystem. 

  6. 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.

  7. "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.

  8. 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.

  9. 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.

  10. 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?