Featured Editorial

  1. Import Product Specifications And Drug Registration Testing For China 10/6/2025

    This overview and its recommendations are valid for drug registration testing (for marketing authorization application in China) as well as import testing (for commercial batches to be imported to China after approval).

  2. Navigating Regulatory Frameworks For Allogeneic CAR-NK Control Strategies 10/3/2025

    The regulatory landscape for this emerging modality is vast and tortuous. One regulatory CMC expert, a former FDA reviewer, helps us with a path through it all.

  3. What If We Had Just One Developability Parameter? 10/3/2025

    Research suggests years-long stability studies that gobble up material can be reduced to a single day using milligram quantities.

  4. Trust But Verify: Validating AI In Pharma's GxP World 10/3/2025

    Here are practical tips to build validated, transparent, and auditable AI systems that align with GxP principles, paving the way for smarter and more resilient manufacturing processes.

  5. What You Should Know About USP's Bioassay Updates 10/2/2025

    The United States Pharmacopeia is overhauling general chapters to align them with current industry standards. One scientist on the project helps us unpack the changes.

  6. On The Ground At BPI: Kat Kozyrytska On Ethical AI And Collaboration 9/29/2025

    AI consultant Kat Kozyrytska advocates for ethical AI adoption and explains its potential to foster collaboration across the industry.

  7. On The Ground At BPI: Takeda's Amy Shaw On Scaling Cell Therapy Manufacturing 9/26/2025

    Takeda head of process development, Amy Shaw, explains what factors to consider when scaling up or scaling out cell therapy manufacturing.

  8. Derisking AI Means First Asking: Who Does It Serve? 9/26/2025

    Ethical and accountability questions still swirl around how we use artificial intelligence in drug development.

  9. A Study In Optimizing Late-Stage Processes With QbD, DoE 9/26/2025

    Nobody wants to redesign analytical process profiles when a market approval is within reach, but what about when a last-lap QbD exercise could bring real benefit?

  10. Automation In The Lab: Lessons From Successes And Setbacks 9/24/2025

    Real-world examples show that, in some labs, manual screenings disappeared altogether, replaced by automated runs that now cover entire departments.