Guest Columns

  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. 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. 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.

  6. 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.

  7. How To Grow CHO Cells Without Cysteine, Tyrosine Feeds 9/19/2025

    Researchers at Pfizer are developing a cell line that synthesizes these amino acids autonomously, which could reduce costs and increase stability.

  8. Why FDA's Tough Talk On Foreign Inspections Is More Bark, Less Bite 9/18/2025

    FDA Commissioner Marty Makary has promised to end the so-called "double standard" of announced overseas inspections. Does the agency have the resources?

  9. Sanofi's Digitalization Road Trip Shifts Into High Gear 9/16/2025

    The company's head of manufacturing discusses their latest investments in AI and automation, plus offers tips on how any company can start adopting advanced technology.

  10. Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms 9/16/2025

    Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events.