Featured Editorial

  1. Plasmid Production: 3 Key Takeaways For mRNA Manufacturing 4/14/2025

    Following my latest Live panel on analytical and manufacturing technology innovations for mRNA production, I wanted to provide a few high-level takeaways I gleaned from our discussion on the overlooked darling of the mRNA space: The plasmid. 

  2. How HHS Budget Cuts And Vaccine Hesitancy Threaten Clinical Trial Operations — And What Leaders Can Do 4/10/2025

    Prof. Stacey B. Lee, Ph.D., examines how the recent Department of Health and Human Services (HHS) staffing cuts and vaccine hesitancy combine to make clinical research much more challenging.

  3. What Happens If The National Cancer Institute Loses Funding? 4/3/2025

    The National Cancer Institute is operating under a continuing resolution that maintains funding at the FY 2024 level of $7.22 billion. But when adjusted for inflation, it effectively reduces the real value of research dollars. So what are the consequences?

  4. Britney Spears' Take On Building Platform Analytics for mRNA Therapeutics 4/2/2025

    As many of the presentations throughout the two-day USP quality forum revealed, we’re doing what we must to understand the benefits and the limitations of our methods. Yes, this is painstaking and expensive work. But understanding our methods is also one of the critical steps toward a future in which we can rely upon platform analytical procedures and — channeling our inner Britney Spears — say “[Ooo], I did it again!” to the regulatory agencies for each of the subsequent molecules in our pipelines.  

  5. Is The mRNA Payload The Real MVP of Targeted Delivery? 3/24/2025

    As one delightfully colorful quote from a panel discussion at the AMM Ascent meeting last fall reminds us, there’s a lot more to be explored, discussed, and understood as it relates to the mRNA cargo’s role in targeted delivery. 

  6. Learning From Oligos: Delivery & Clinical Strategies For mRNA Therapeutics 3/17/2025

    Those of us who attended the Alliance for mRNA Medicines’ inaugural Ascent conference last fall had the opportunity to hear from Zdravka Medarova of TransCode Therapeutics on her experiences working in the oligo sector. Here, I summarize some of her learnings and/or suggestions for the encoding RNA field as we set out to develop mRNA therapeutics for oncology.

  7. MHRA Issues New Regulation On Modular And Point Of Care Manufacture Of ATMPs 3/11/2025

    The U.K.'s MHRA has issued a new regulation to allow for decentralized manufacturing of cell and gene therapies (advanced therapeutic medicinal products), describing modular and point of care manufacturing. It becomes effective July 23, 2025.

  8. 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. 

  9. 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.

  10. Courtroom Clash: Inside The High-Stakes World Of mRNA Patent Litigation 2/28/2025

    Here, Shores provides the “who’s who” and “what’s what” behind some of the hottest legal cases to hit the headlines in the mRNA space to-date, as well as why these cases are or could be significant to companies commercializing mRNA products in the future.