RNA Outsourcing Articles

  1. 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.

  2. 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.

  3. How Pharma 4.0 Can Unlock The Full Potential Of External Manufacturing 2/27/2024

    To address today's challenges and other headwinds, pharma/biotech organizations and CMO/CDMO partners need to re-evaluate and improve externalized operating models. Consider further investing in digitalizing collaboration processes as part of operational excellence and digital transformation road map efforts. 

  4. 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.

  5. How Strategically Partnering With Academia Supports Biotech R&D Goals 9/14/2023

    For early-stage biotechs, partnering with leading academic institutions can help your firm cut costs and boost the returns on R&D investments while making key research and industry connections that can assist in the development, and ultimate commercialization, of your drug/therapy products.

  6. 4 Risk Mitigation Strategies For mRNA Production 4/17/2023

    Planning and procuring custom materials needed to manufacture mRNA remains a top concern. This article shares risk mitigation strategies for multi-sourcing, S&OP process, packaging size, and material expiry.

  7. Moderna's Global mRNA Manufacturing Strategy: A Closer Look 3/27/2023

    In part 2 of this 3-part series, I argue Moderna’s strategy for scaling its mRNA vaccine manufacturing paradigm globally is one of the best examples the ATMP space has today of what it means to begin with and keep the end in mind.

  8. Moderna And The Building Of Bridge Facilities 2/27/2023

    In August of 2021, relatively overlooked because of other news swirling around our industry, Moderna became the anchor client in a new cleanroom on demand housed in a bridge facility in Massachusetts. In retrospect, it may have legitimized a new era in outsourcing.

  9. 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.

  10. Biomanufacturing Capacity Crunch: It's The Supply Chain's Fault 10/7/2022

    What's behind the protracted biopharma manufacturing capacity crunch, when will it end, and what are manufacturers doing to keep supply on track? During Biotech Week in Boston ad BioProcess International, CDMOs and sponsors weighed in.