Guest Columns

  1. Avoiding Alcohol-Induced Dose Dumping In Oral Drug Formulation 8/21/2025

    The FDA has become more vigilant about alcohol-induced dose dumping in extended-release oral dosages. Such dumping can result in anything from reduced therapeutic effects to dangerous toxicity. Let's take a closer look.

  2. Calculating The Right In-House/Outsource Mix For ADC Manufacturing 8/21/2025

    Antibody-drug conjugate innovators often question whether to outsource manufacturing activities or bring them in-house. Here are some key considerations.

  3. Case Studies: Is AI Making Biologics And CGT Outsourcing Smarter? 8/20/2025

    This continues our discussion of AI and CDMOs, focusing on biologics and cell and gene therapy (CGT) relationships. Outsourced Pharma Board Member Vadim

  4. Report: Nearly 40% Of Biomanufacturers Eyeing Continuous Processing 8/19/2025

    Continuous perfusion manufacturing came about before the technology was mature enough to support it. Now, new data suggests an inflection point in the status quo.

  5. Advancing CAR T Cell Therapy with Logic Gate Engineering 8/19/2025

    Logic gating applies Boolean logic principles to CAR T cell design to improve precision and minimize collateral damage.

  6. Blood Plasma Fractionation: Engineering And Facility Design For The Future Of Biotherapeutics 8/15/2025

    This article shares key considerations for bioprocessing facility design for plasma-derived medicinal products.

  7. Navigating Contract Manufacturing Agreements: Tips And Pitfalls For Pharma And Biopharma Companies 8/13/2025

    When choosing the correct contract manufacturer, it is critical to negotiate a proper manufacturing agreement to define the relationship between all parties, allocate risks, and ensure all requirements are met with regard to legal, product specification, and IP matters.

  8. How AI Is Revolutionizing Quality Management Systems 8/13/2025

    The real question isn't whether pharmaceutical companies should adopt AI in their quality systems, but how to implement it effectively and what specific benefits to expect.

  9. Lean Manufacturing Implementation In Pharmaceutical Injectable Facilities 8/12/2025

    This comprehensive analysis examines lean manufacturing implementation challenges and evidence-based solutions derived from leading pharmaceutical organizations. 

  10. July 2025 — CDMO Opportunities And Threats Report 8/11/2025

    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.