ARTICLES BY JON O'CONNELL

• Fine-Tuning Bioseparation Column Geometry With 3D-Printed Monoliths

  11/3/2026

  If geometric control, not retention, is the priority in viral vector separation, research group says high-resolution 3D-printing chromatography monoliths can be useful.

• ICH M4Q(R2) And M16 Modernize The CTD For Digital Submissions

  9/28/2026

  A former FDA assessor explains how recent changes to the common technical document bring long-overdue updates to the submission process, accounting for greater data demands.

• Sustainable Facility Design Brings Bayer Instant Savings

  9/23/2026

  ROI for sustainability initiatives often come later as lower maintenance and utility costs. Bayer's pursuit of LEED certification led to substantial savings up front.

• New USP Guidelines, Standards Address Lentivirus Characterization

  9/16/2026

  The United States Pharmacopeia is rolling out new standards and tools to help manufacturers characterize fragile, complex lentiviral vectors.

• 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.

• 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.

• 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.

• 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.

• 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.