JON O'CONNELL ARTICLES

• Bringing Next-Gen Sequencing To GMP Scale

  9/10/2026

  NGS enables broad detection of known and novel viruses in a single assay. Its high sensitivity, specificity, and scalability can meet GMP throughput levels.

• Risk Managing Through The Void Of ATMP Visible Particle Guidance

  9/8/2026

  Regulators expect cell therapy manufacturers to prove they control for visible particles, but guidance remains notably quiet on the matter. Companies must get creative or risk clinical holds.

• 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.

• When To Trust And When To Verify AI-Enabled Validation Systems

  9/3/2026

  Computer software assurance, coupled with AI, can help validation teams reduce redundant work and spend more time on patient-centric issues.

• A QMS That Anticipates Cell And Gene Therapy Quality Challenges

  9/2/2026

  Some quality system elements are non-negotiable in Phase 1 cell and gene therapy. For the rest, a risk matrix can help define flexible, defensible specifications.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• A Peek Into Novo Nordisk's Sustainable Facility Construction Mindset

  2/18/2026

  Fill/finish operations are famously resource-heavy. Nonetheless, Novo set out to achieve ambitious environmental goals with its $4.1 billion project in North Carolina.

• 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.

• Ask The Pros — The Latest In HCP Monitoring

  12/4/2025

  Established methods focused on counting all HCPs indiscriminately. Now, a new wave of sophisticated monitoring offers clearer impurity profiles.

• Lessons In Quality From Sanofi's Plai.qa

  11/24/2025

  The platform orchestrates data to evaluate site maturity and performance and provide recommendations for improvement.

• Here's What You Need To Know About The Access Consortium Pathway

  11/20/2025

  Five nations are collaborating on a work-sharing program to reduce regulatory duplication in drug development.

• FDA Draft Guidance On CES Signals More Reliance On Toxicity And PK

  11/19/2025

  The technology to measure alternative metrics is vastly improved. Now, FDA joins other regulators in deprioritizing comparative efficacy studies for biosimilars.

• Exploring The Benefits Of Electroporation In NK Cell Transfection

  11/14/2025

  Electroporation creates temporary holes in cell membranes for genetic material to slip through. The technique offers some key advantages to viral transduction.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• A Study In Optimizing Late-Stage Processes With QbD, DoE

  9/26/2025

  Nobody wants to redesign analytical process profiles when a market approval is within reach, but what about when a last-lap QbD exercise could bring real benefit?

• Derisking AI Means First Asking: Who Does It Serve?

  9/26/2025

  Ethical and accountability questions still swirl around how we use artificial intelligence in drug development.