Industry Insights

  1. 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.

  2. Disciplined CGT Will Win On 2026 Regulatory Flexibility 1/29/2026

    Wilson Bryan, M.D., and Daniela Drago, Ph.D., RAC, joined our our first Cell & Gene Live of 2026 to unpack what a more mature era of regulatory oversight means for sponsors.

  3. In Vivo's Biggest Threat — Comparison To Old Models 1/23/2026

    In vivo CAR-T is not simply ex vivo without a manufacturing step. It is a different modality that relies on biological systems to regulate outcomes.

  4. The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing 1/21/2026

    The promise of AI is colliding with the harsh reality of data chaos in pharma manufacturing. This article explores why most AI investments fail, and a 5-layer solution.

  5. Why Use Total Organic Carbon Analysis For Cleaning Validation? 1/21/2026

    Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.

  6. December 2025 — CDMO Opportunities And Threats Report 1/20/2026

    Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

  7. The Great Cell Therapy Reset: Solving The Industrial Math Of Living Drugs 1/15/2026

    The cell therapy sector is experiencing a paradigm shift in manufacturing: from bioreactor (ex vivo) to body (in vivo).

  8. Single-Use Standards Are Maturing, But The Process Remains King 1/13/2026

    The food industry inspired single-use in biopharma, but the regulatory landscape is far more complex. If you're worried about compliance, this discussion can help.

  9. ARM's Tim Hunt On Expanding Patient Access, Smarter Regulation, And A More Sustainable Market In 2026 1/12/2026

    ARM's Tim Hunt outlines how smarter regulation, evolving payment models, and global competition are reshaping CGT into a more accessible and commercially sustainable industry.

  10. Deploying A Vendor Life Cycle Oversight Model 1/9/2026

    A practical guide for adding oversight, based on a hierarchy of metrics, to quality agreements to transform them into living, metrics-driven control instruments.