Guest Columns

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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?

  7. 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.

  8. Defining Strong Program Management In CDMO Partnerships 9/23/2025

    This first article of a planned three-part series discusses the pitfalls that program managers help sponsor companies avoid, how program managers accelerate timelines or reduce risk, and more.

  9. CGT Success Starts With The First Mile 9/23/2025

    The so-called "last mile" in cell therapy gets a lot of attention. What about the first mile, the journey cells take between the donor and the manufacturing site?

  10. Can CHO Bioreactors Be Used For Plant-Based Protein Production? 9/22/2025

    The moss Physcomitrium patens is especially good at producing glycoproteins. Established technology and prior knowledge are helping one company develop new therapies with it.