ARTICLES BY JON O'CONNELL

• Building Trust In AI For Computerized System Validation

  9/4/2026

  Using AI for CSV might feel like the students are grading their own papers. One consultant explains why it's not the same, namely, there are no subjective judgment calls.

• A Gentler Cell Line Selection Method Using microRNA

  9/4/2026

  Traditional selection stresses surviving cells. New research shows how structurally interacting RNA may use endogenous microRNA for a faster, nontoxic selection process.

• Implementing AI Solutions In GMP While Managing Risk

  8/28/2026

  When using artificial intelligence in GMP settings, risk management extends far beyond  validation. This discussion explores moving AI solutions out of the pilot phase.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.