RNA Analytical/Quality Articles

41. mRNA: The Fourth Pillar Of Pharmaceutical Innovation And Intervention 4/26/2024

    mRNA medicines represent the genesis of a fourth pillar of pharma innovation. While exciting, there are several critical challenges we must solve to strengthen this pillar, including stability and deliverability.

42. ARW's ATMP Manufacturing Must-Reads (ST. PATRICK'S DAY EDITION!) 3/14/2024

    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 roundup article.

43. “To Thine Own [mRNA Product] Be True:” Shakespeare's Guide To RNA GMP Principles 3/11/2024

    In the following article, I offer some of the biggest tips and tricks experts offered during a panel discussion on the challenges of navigating GMP principles in the RNA space today — with a little bit of help from Shakespeare himself. 

44. Future-Proofing mRNA Drug Manufacturing: IVT And Supply Chain 2/29/2024

    Regulatory and technical uncertainty surrounding mRNA necessitates predictive and proactive innovation enabling better manufacturability assessments, more robust in vitro transcription techniques, and improved downstream processing.

45. Comparability Considerations For mRNA Product Development 2/28/2024

    Given the mRNA-based products' variability and unique challenges, you may need to modify the standard comparability approach. Let’s discuss strategies for any development stage.

46. 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.

47. 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.

48. 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.

49. 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.

50. 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.