RNA Analytical/Quality Articles

41. ARW's ATMP Manufacturing Must-Reads (OPERA EDITION!) 2/8/2024

    Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email.

42. From “Barbieland” To ATW 2024: Evolving Beyond “Stereotypical” Advanced Therapies 1/26/2024

    What I was met with this year at Phacilitate's Advanced Therapies Week was an industry that knows its worth, but which is facing similar issues as Barbie around what its long-term identity can be and how it can transcend beyond being just a promising idea. Here, I’ve come up with a few snippets of “identity-chiseling” wisdom for the ATMP space.

43. ARW's ATMP Manufacturing Must-Reads (2024 NEW YEAR'S RESOLUTIONS EDITION!) 1/12/2024

    Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email.

44. Cell & Gene Therapies: How Can Our Knowledge Of 2023 Inform Our Predictions For 2024? 1/8/2024

    2024 promises a potential turnaround and blue skies for cell and gene therapies. Let’s explore each modality’s prospects: oligos and mRNA, cell therapies, and viral gene therapies.

45. Understanding CQAs For mRNA/Lipid Nanoparticle Product Development And Manufacture 12/13/2023

    BioPhorum recently created a resource of potential critical quality attributes (CQAs) for mRNA products from the early stages of drug development to commercial manufacturing. We asked two of the paper’s authors some questions to explore the key areas in more detail.

46. 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.

47. 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).

48. 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.

49. 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.

50. 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.