RNA Analytical/Quality Articles

51. Peter Marks: An Early Preview of mRNA, Gene Therapy Platforms 11/28/2023

    Though Marks emphasized that this concept/designation at the regulatory level is still somewhat of a “we’ll-know-it-when-we-see-it” phenomenon, his remarks this summer — as well as a few additional discussions that have occurred throughout 2023 — add a bit more clarity to our understanding of what a gene therapy platform can be.

52. What We Need To Unlock Next-Generation mRNA Therapeutics 11/13/2023

    mRNA is an incredibly nimble platform for drug discovery and development, but in order to truly unlock the next generation of mRNA therapeutics, we need to think outside the box (and we also need more funding).

53. New Developments In mRNA Vaccine Efficacy Show Promise 11/1/2023

    Significant caveats with the current base modification approach for mRNA vaccines still remain and need to be addressed. This article looks at activation of innate immunity, overcoming the limitations of pseudouridine, novel 3-base oligonucleotides, and more.

54. FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities 10/25/2023

    The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.

55. The Regulatory Genome: “Digital Software” For Drug Development 9/22/2023

    Next-generation sequencing (NGS) has allowed the industry to uncover all aspects of genomic activity, including the 98% of the traditionally unexplored genome, now known as the regulatory genome. Let's explore RNA as "digital software" for drug development, a look beyond NGS, and the role of long-coding RNAs in particular.

56. Guidelines For mRNA Drug Product Manufacturing And Quality Control 9/15/2023

    The lightning fast rise of mRNA raised the need for manufacturing standards and consensus on product quality attributes and test methods. This article provides perspective and insight on PQAs for mRNA vaccines and other mRNA-based products.

57. Beyond Moderna's Regulatory Legacy: (Re)defining The mRNA Regulatory “Norm” 3/22/2023

    It’s unlikely we will need to burn nearly as much “midnight oil” as Moderna and the regulatory bodies did during the pandemic. However, I share Moderna's unique experiences because they’re a great reminder that the mRNA therapeutics industry is set to face a much different regulatory challenge moving forward.

58. Moderna's Regulatory Journey: 3 Takeaways To Foster The mRNA Renaissance 3/22/2023

    We may no longer be living in the fast-and-furious days of Emergency Use Authorization, nor are we all working strictly on mRNA vaccines. But after listening to Moderna’s Director of Regulatory CMC Chris Kelly share his whirlwind regulatory experiences, there were still several broad takeaways for companies navigating this nascent space.

59. Defining The RNA Therapeutics Industry In 2023 1/16/2023

    Four executives outline which industry challenges, strategic considerations, and opportunities should be top of mind as RNA therapeutics companies establish their to-do lists for 2023.

60. mRNA & RNA Therapeutics In 2023: Where Do We Go From Here? 12/7/2022

    To figure out what the future holds for companies in the RNA sector of the ATMP space, I sat down with four executives to discuss their wildest hopes, dreams, and expectations. As you’ll note, there is no shortage of work facing the RNA therapeutics industry in the year(s) ahead. But there’s also a lot for which we can hope.