Guest Columns

  1. FDA Issues Draft Guidance On The Use Of AI To Support Regulatory Decision-Making For Drug And Biological Products 2/14/2025

    The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. The public comment period ends April 7.

  2. Ensuring Repeatable, Viable Surface Sampling In Aseptic Settings 2/14/2025

    Without high quality data, surface sampling simply becomes another exercise in checking regulatory compliance boxes.

  3. January 2025 — CDMO Opportunities And Threats Report 2/12/2025

    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.

  4. Emerging Trends In mAbs Manufacturing In 2025 And Beyond 2/11/2025

    Two key innovations — continuous perfusion in upstream processing and multicolumn chromatography in downstream processing — are having a profound impact on biologics manufacturing.

  5. FDA Finalizes Guidance On The Advanced Manufacturing Technologies Designation Program 2/10/2025

    The FDA released final guidance on the Advanced Manufacturing Technologies Designation Program at the end of December. This article shares a summary, analysis, and how it compares to the 2023 draft.

  6. A Look At Pharmaceutical Inspection Machine Advanced Technologies 2/7/2025

    Pharma and biotech companies are increasingly using inspection machines with advanced technologies, such as x-ray inspection, robotics, and more, to help them get ahead of the competition.

  7. Automating Digital Twins Implementation In Downstream Bioprocessing 2/7/2025

    One researcher describes a case study in which they simply pressed play on a set of six pre-programmed experiments and returned hours later to a complete data set.

  8. Comparison Of Sterilization Methods: Vaporized Vs. Aerosolized Hydrogen Peroxide 2/5/2025

    Hydrogen peroxide (H2O2) is one of the most frequently used chemical compounds for sterilization. This article compares the benefits and trade-offs of using the vapor form vs. aerosol form.

  9. A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices 2/3/2025

    Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Relational risk analysis (ReRA) fundamentally changes the way risks are analyzed.

  10. New AAV Reference Standards To Aid CQA Assessment 1/31/2025

    AAVs' complexity makes them difficult analytical testing subjects. The second part of a series describes USP's latest effort to help characterize the viral vectors.