ARTICLES BY JON O'CONNELL
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![Medical research-GettyImages-1287846309]( "A QMS That Anticipates Cell And Gene Therapy Quality Challenges")
A QMS That Anticipates Cell And Gene Therapy Quality Challenges9/2/2026Some 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.
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![Modern Technology, artificial intelligence, machine learning-GettyImages-2211392347]( "AI Has Arrived In Biotech CMC Amid Patchwork Governance")
AI Has Arrived In Biotech CMC Amid Patchwork Governance6/3/2026AI 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.
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![test tubes, dropper, glass vials, pharmaceutical innovation-GettyImages-2157720330]( "How Sethera Harnesses A Promiscuous Enzyme To Make Recombinant Peptides")
How Sethera Harnesses A Promiscuous Enzyme To Make Recombinant Peptides10/21/2025A class of enzymes previously believed to be specific and intolerant of change might actually have broad applicability.
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![GettyImages-1493586956-assay-bottles-laboratory-scientist]( "What You Should Know About USP's Bioassay Updates")
What You Should Know About USP's Bioassay Updates10/2/2025The United States Pharmacopeia is overhauling general chapters to align them with current industry standards. One scientist on the project helps us unpack the changes.
Jon O'Connell
Jon O’Connell is the executive editor for Bioprocess Online, a leading publication within the Life Science Connect family. With a career rooted in high-stakes journalism, Jon oversees critical content focused on biopharmaceutical manufacturing and clinical trial supply. His editorial lens covers the entire biologics lifecycle — from early-stage process development to final packaging — with a steadfast mission to streamline industry workflows and accelerate the delivery of life-saving therapies to patients. An award-winning journalist, Jon’s work has been recognized by the Keystone Society of Professional Journalists and the Pennsylvania AP Managing Editors. In 2020, he was awarded a prestigious National Press Foundation fellowship to study cancer research, further deepening his technical expertise in the oncology space. Whether hosting the Business of Biotech podcast or moderating industry-shaping Q&As, Jon remains dedicated to bridging the gap between complex science and actionable business intelligence.