JON O'CONNELL ARTICLES

• 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.

• 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.