Jon O'Connell Articles

  1. Dual Membrane Preconditioning Can Improve Concentration, Cut HCPs 10/27/2025

    Research from Penn State, the FDA, and Takeda shows how combination filtration and purification steps improve output and reduce impurities.

  2. New Guide Aims To Build Robust Framework For Digital Validation Tools 10/22/2025

    The ISPE's new guide addresses software for managing digital assets related to qualification, verification, validation, and compliance assurance.

  3. Pfizer's Accord For A Healthier World Program Challenges Stability Study Norms 10/22/2025

    The company developed a novel approach to address the historic lack of stability testing for underserved parts of the world, near the equator.

  4. How Sethera Harnesses A Promiscuous Enzyme To Make Recombinant Peptides 10/21/2025

    A class of enzymes previously believed to be specific and intolerant of change might actually have broad applicability.

  5. Takeda Reimagines Biopharma Quality For The Digital Age 10/21/2025

    Artificial intelligence, even in its current form, is especially good at synthesizing large data sets. Here's how one company makes the most of it.

  6. 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.

  7. 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.

  8. 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?