Jon O'Connell Articles

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.