Jon O'Connell Articles

  1. What Reliance, Annex 1, And AI Mean For The Future Of GMP 5/29/2026

    EMA’s Brendan Cuddy explains how regulators are adapting oversight to global supply chains, new technologies, and growing operational complexity.

  2. A Multi-Agent Audit Intelligence Framework For CDMO Quality Oversight 5/18/2026

    A Takeda quality executive demonstrates how a team of AI agents uses synthetic data to provide decision support ahead of CDMO audits.

  3. Repeating Sanofi's Ballroom Design On Two Continents 5/15/2026

    Moveable walls and a stunning number of robotics at its sites in France and Singapore, among other features, has earned Sanofi international recognition for innovation.

  4. Inside March Biosciences' CD5-Targeting CAR-T Approach 5/4/2026

    Fratricide is one of the key reasons T-cell therapies targeting T-cell malignancies have faltered. March's approach aims to solve that with its MB-105 candidate.

  5. The Stepwise Path Lilly Mapped From Paper To Digital Logbooks 4/30/2026

    Eli Lilly and Company started at the front lines, on the shop floor gathering operator input, when switching from paper to digital logbooks.

  6. Validating Candel's BLA-Ready Analytics Profile 4/22/2026

    The adenovirus/prodrug company discusses in-house assay development and the validation work to confirm CQAs like potency and cell line integrity.

  7. Mapping Candel Therapeutics' Sprint To The BLA Finish Line 4/22/2026

    Leaders from the adenovirus/prodrug developer discuss the complex balancing act of preparing to scale up for commercial manufacturing without overextension.

  8. Lilly's Unified Mindset For A Global Parenteral and Device Manufacturing Network 4/17/2026

    Eli Lilly and Company's one-team mindset aims to templatize facility design while remaining nimble enough to react to new manufacturing breakthroughs.

  9. Dynamic Flux Analysis Offers Faster Metabolic Modeling Than DOE 2/27/2026

    By continuously analyzing spent media, researchers can estimate reaction rates at regular time points, providing a granular view of cell metabolism.

  10. A Novel In Vitro Glycosylation Approach For Difficult PTMs 2/19/2026

    Post-translational modifications of membrane proteins have been historically challenging. Research shows how an in vitro approach brings stability and predictability.