Jon O'Connell Articles

41. It's Not Just You, Everyone's Talking About OPV 11/12/2025

    Ongoing process verification has evolved beyond a compliance exercise to a strategic priority thanks, in part, to technology advancements.

42. A Multi-Omics Approach For Characterizing Clinical-Scale iPSC Batches 11/6/2025

    The transition from 2D to 3D cell culture requires a combination of advanced analytical techniques, but aligning new methods with established principles can be challenging.

43. The Transition To E-Labeling Is More Than Uploading PDFs 10/31/2025

    Despite tight restrictions, patchwork regulations, and an unclear timeline, one researcher says we're heading toward fully-digitalized drug labels.

44. Here's A Thought: What If Gene Editing Didn't Use Bacterial Enzymes? 10/27/2025

    Citing the dismally few wins for CRISPR/Cas9 and other gene editing systems, one scientist proposes delivering zinc finger DNA-binding peptides using AAV6 vectors.

45. 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.

46. 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.

47. 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.

48. 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.

49. 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.

50. 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.