Featured Bioprocessing Editorial

  1. September 2026 — CDMO Opportunities And Threats Report 10/28/2026

    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.

  2. An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs? 10/28/2026

    FDA’s real-time CRL releases face legal and operational hurdles. Could AI-assisted redaction make transparency faster and more consistent?

  3. Navigating Outsourced Pharmaceutical Testing Through Today's Geopolitical Uncertainty 10/22/2026

    Geopolitical shocks are reshaping outsourced pharmaceutical testing. Learn how procurement teams can strengthen resilience and protect continuity.

  4. Is Your Supply Chain Ready For The End Of Class VI? 10/21/2026

    Revisions to USP <87> and <88> update biological reactivity testing — changes that are especially important for companies that rely on single-use technology.

  5. When Lyophilization Fails At Scale, First Scrutinize Your Formulation 10/16/2026

    When lyophilizing a challenging biologic drug product, use an integrated approach optimizing formulation and process parameters together.

  6. The 5 Shifts That Could Remake Lyophilization By 2040 10/15/2026

    Purdue University-based LyoHUB charts a risk-based course to modernizing freeze-drying technology for better performance and advanced modalities.

  7. Complete Response Letters For CGTs Share This Common Theme 10/7/2026

    One expert’s analysis found CMC-related concerns in about 75% of complete response letters. He outlines a path to stronger CMC readiness for cell and gene therapies.

  8. Your 7 Decisions To Make Before MES Configuration 10/7/2026

    Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.

  9. DEA Reveals Hidden Costs Of Analytical Validation Guidelines 10/2/2026

    By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.

  10. Qualification And Validation Of Depyrogenation Tunnels And Autoclaves 10/2/2026

    Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization.