ARTICLES BY JON O'CONNELL

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• Using Carbon Nanotubes To Pinpoint Optimal Harvest Time in Bioprocessing

  2/18/2026

  Cell-free expression systems confound the moment of peak expression. These nanosensors signal through crude lysate for process optimization and endpoint monitoring.

• This Industrial Fungus Has Protein Expression Promise For Pharma

  2/12/2026

  Trichoderma reesei is well characterized for industrial uses. A Finnish research group is exploring it for pharmaceutical protein expression.

• New ISPE Framework Targets Uncertainty In Pharma's AI Deployment

  1/29/2026

  International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.

• The Module Type Package Wants All Your Equipment To Start Talking

  12/11/2025

  A forthcoming ISPE guide uses case studies to aid in the design of plug-and-play process skids with implications for every step in the manufacturing process continuum.