Featured Editorial

  1. Scaling RNA Production From The Lab To The Clinic 8/9/2024

    Nutcracker's unique approach to scaling up to clinical manufacturing — which brings unique challenges compared to traditional biologics — relies on microfluidics.

  2. Clinical Trial QA Strategies In Low- And Middle-Income Countries 8/9/2024

    This author shares key learnings and insights around quality assurance coming out of Gates MRI's vaccine clinical trials in low- and middle-income countries.

  3. The Real Cost Of Poor Quality — And What You Should Do About It 7/30/2024

    It is well recognized that poor quality can lead to supply disruption. To drive positive change, the sector should seek to greater enhance quality maturity.

  4. FDA Finalizes Guidance About Delaying, Denying, Limiting, Or Refusing An Inspection 7/25/2024

    The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.

  5. Does Single-use Seem Daunting? Try Starting With Standard Assemblies 7/8/2024

    You might not need to outfit your whole facility to take advantage of single-use technology. Assemblies offer a straightforward path to standardizing equipment.

  6. Making Cancer Vaccines Is Complex; New Platform Guidance Could Help 7/3/2024

    FDA's draft guidance on platforms is mostly for established, well-characterized modalities, but it also has implications for the emerging area of personalized medicine.

  7. New 'WEE' Urgency Raised As FDA Requires DSCSA EDDS Interoperability 6/28/2024

    A June meeting showed industry is struggling to meet the DSCSA's November deadline. Eligible companies might find relief in an FDA waivers and exemptions program.

  8. Strategies To Tackle CAR-T Product Challenges 6/24/2024

    This article describes strategies for scaling up production of CAR-T products, including the hub model, bedside model, innovation of process strategy, and more.

  9. Chugai's Race To Zero Emissions At UK4 In Tokyo 6/21/2024

    Chugai's sustainable model led the construction of a new DS/DP manufacturing site, UK4, in Tokyo. The company focused on eliminating three key emissions sources.

  10. Have We Got Novel Drug Production And Compliance Timelines All Wrong? 6/13/2024

    Drug developers might want to consider longer-term approaches to meeting manufacturing and regulatory requirements.