RNA Manufacturing Articles

81. 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.

82. Tracking 4 Payload Trends In Drug Delivery Development 1/22/2024

    Amid new research and development in nanocarriers, market attention has shifted toward payloads and enhancing compatibility. This discussion explores the latest trends and includes a research database.

83. 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.

84. Why Nike's "Just Do It!" Is The Wrong Slogan For The RNA Industry 1/10/2024

    As Becraft and I discuss, it’s not just the public we need to educate about the possibilities and limitations of mRNA therapeutics. Members of the biopharmaceutical industry at large and the investors supporting emerging and established RNA therapeutics companies could also use a post-pandemic “refresher” about mRNA’s potential use cases beyond vaccines and the (often under-emphasized) truths of what it will take to successfully achieve these use cases.

85. 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.

86. A Meditation on mRNA's Reputation & Regulatory Complexities 12/21/2023

    I see our modality’s capability to be used in the vaccine and ATMP spaces posing some unique challenges for the RNA space moving forward — particularly as we strive to accomplish two key goals as a space: fleshing out the mRNA regulatory paradigm and confronting misinformation in the years ahead. 

87. How To Break RNA's “4-Minute Mile” 12/20/2023

    Four CEOs provide their take on some of the hot topics of discussion in the RNA therapeutics space. Whether they be homing in on platform development, much-needed scientific advancements, or commercialization considerations, each of these experts’ quotes speaks to the important “training efforts” we should be building into our “workout” regimens to condition our companies and our products to achieve (and surpass!) RNA’s own “four-minute mile(s).”

88. 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.

89. 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.

90. Achieving Flexibility In RNA Drug Manufacturing With Microfluidics 11/21/2023

    RNA manufacturers need flexible processes and technology. They need to manufacture high-quality RNA in small quantities and scale up. Modular, and more specifically, modular microfluidics equipment makes that easier. This discussion takes stock of the current state of modular equipment for RNA manufacturing.