RNA Manufacturing Articles

  1. Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers 4/17/2025

    The U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts. 

  2. Implement Creative And Collaborative Strategies to Optimize Your mRNA Development And Manufacture 4/15/2025

    No matter how you approach it, mRNA manufacturing is expensive. The raw materials, technologies, and educated labor force require immense investment. To avoid incurring extra costs and to ensure your strategy is precise and risk averse, identify an experienced partner that prioritizes communication and first-time-right manufacturing.

  3. Plasmid Production: 3 Key Takeaways For mRNA Manufacturing 4/14/2025

    Following my latest Live panel on analytical and manufacturing technology innovations for mRNA production, I wanted to provide a few high-level takeaways I gleaned from our discussion on the overlooked darling of the mRNA space: The plasmid. 

  4. MHRA Issues New Regulation On Modular And Point Of Care Manufacture Of ATMPs 3/11/2025

    The U.K.'s MHRA has issued a new regulation to allow for decentralized manufacturing of cell and gene therapies (advanced therapeutic medicinal products), describing modular and point of care manufacturing. It becomes effective July 23, 2025.

  5. The mRNA Industry's Three Wishes: Can CDMOs Play The "Genie?" 3/5/2025

    During the panel discussion last November, three CDMO execs shared the biggest scientific, regulatory, and technological complexities barring a “magical” solution to each biotech’s wishes. However, as each of the AMM panelists pointed out, there are short- and long-term technological innovations in the works that will be essential in advancing the manufacturing infrastructure for mRNA therapeutics in all their shapes, forms, and scales. 

  6. Understanding The New U.K. MHRA 'Draft Guideline On Individualised mRNA Cancer Immunotherapies' 3/5/2025

    The U.K.'s MHRA has released a new draft guideline outlining best practices for drug product design, CMC, and manufacturing of mRNA cancer immunotherapies using LNP delivery systems. The public comment period ends March 31.

  7. Courtroom Clash: Inside The High-Stakes World Of mRNA Patent Litigation 2/28/2025

    Here, Shores provides the “who’s who” and “what’s what” behind some of the hottest legal cases to hit the headlines in the mRNA space to-date, as well as why these cases are or could be significant to companies commercializing mRNA products in the future.

  8. 10 Ways To Speed Up CMC In Early-Stage Drug Product Development 2/21/2025

    The inherent complexity of living cell-based products, vector-based gene therapies, and highly sensitive analytical methods demands robust change management strategies.

  9. How Automation And AI Can Accelerate Clinical Research And Outbreak Response 2/18/2025

    Explore AI-driven automation and organ-on-a-chip technology to accelerate infectious disease research, enhancing assay efficiency, and improving vaccine and therapeutic development for emerging global health threats.

  10. Cultivating A Thriving mRNA Ecosystem: Key Initiatives & Future Directions 2/13/2025

    Overall, I felt that the following initiatives/talking points were demonstrative of the types of creativity and symbiosis that we will need much more of in the near and long-term to foster a healthy and fruitful RNA ecosystem.