Jon O'Connell Articles

  1. Enzyme Activity As A Surrogate Potency Marker In Cell Therapy 8/26/2026

    When measuring cell therapy potency, biochemical assays can provide a rapid alternative to the time- and material-consuming standard of cell-based assays.

  2. What Goes Into Restarting A Shelved Orphan Drug Candidate? 8/19/2026

    The Orphan Therapeutics Accelerator wants to help viable clinical-phase products reach patients. Its cofounder describes the complexity of rebooting a shelved candidate.

  3. Building A Self-Driving Lab For LNP Development 7/20/2026

    With commercially available components, MIT researchers built a platform that accelerates LNP process development, optimization, and autonomous manufacturing research.

  4. Exploring Takeda's Template For Sustainable Steam Generation 7/17/2026

    Takeda designed a model for delivering steam at 11 bar and up to 184 degrees using natural refrigerant and waste heat at one of its largest production sites.

  5. Addressing The Particulate Challenge In Cell Therapy Products 7/15/2026

    Cell therapy products challenge traditional particulate controls. One expert explains detection, mitigation, and contamination prevention.

  6. An Open-Source Modeling Tool For Suspended Continuous Lyophilization 7/7/2026

    Building on a continuous suspended-vial lyophilization workflow, process developers can model critical variables before doing physical experiments.

  7. What Biopharma Often Overlooks In A Scheduled Shutdown 6/26/2026

    Shutting down an operating biologics facility upsets systems often designed for continuous operation. One expert shares his tips for preventing unnecessary problems.

  8. Is Your AI Model Trustworthy And Credible In GMP Processes? 6/17/2026

    Credibility and trustworthiness in AI models are related but distinct attributes. If you're using them in GMP manufacturing, you should understand the difference.

  9. Where Does 3D-Printed Single-Use Tech Fit In The Development Pipeline? 6/10/2026

    Additive manufacturing in early-phase process development is growing more common, but the practice comes with important considerations.

  10. AI Has Arrived In Biotech CMC Amid Patchwork Governance 6/3/2026

    AI is surfacing within regulatory and CMC workflows at a vigorous pace. Unfortunately, in small and midsize biotechs, it's happening faster than governance can keep up.