BIO From The Editor and Guest Columns

  1. Do Patient Needs Define Biologic Product Specifications? 3/14/2025

    Enhanced product understanding acknowledges the technology advancements of the last 25 years and substantially more complex drug modalities.

  2. Are CDMO Partnerships The Answer To Manufacturing Capacity Issues? 3/13/2025

    The current manufacturing strain is exacerbated by factors such as the intensity of scaling up fill-finish and specialized manufacture of drug delivery devices. How can partnering with a CDMO help?

  3. A Snapshot Of What Pfizer's Doing With Teleoperated Robots 3/12/2025

    A robotic arm controlled with a virtual reality headset and input devices could aid in complex interventions where automation isn't practical.

  4. Retrofitting Facilities For Modern Bioprocessing And Pharma Production 3/11/2025

    The U.K. National Health Service is developing a former warehouse into a multi-modal aseptic manufacturing hub. The project's production head talks pros, cons, and strategy.

  5. MHRA Issues New Regulation On Modular And Point Of Care Manufacture Of ATMPs 3/11/2025

    The U.K.'s MHRA has issued a new regulation to allow for decentralized manufacturing of cell and gene therapies (advanced therapeutic medicinal products), describing modular and point of care manufacturing. It becomes effective July 23, 2025.

  6. Intensifying Downstream Processing With Magnetic Separation 3/10/2025

    A technique used widely in other industries like steel production and wastewater treatment has emerged as rising star within bioprocessing over the last 10 to 15 years.

  7. Trends In FDA FY 2024 Inspection-Based Warning Letters 3/7/2025

    Of the 190 warning letters that the FDA issued to drug and biopharma manufacturers in fiscal year 2024, this article provides a deep dive on trends pertinent to the 111 inspection-based letters. You may be surprised at some of them.

  8. AI Performance Management In Biologic And Drug Development 3/7/2025

    Life cycle maintenance is essential in AI-driven drug development. Regulators recommend continuous updates to AI models to monitor and adjust for data pattern changes.

  9. February 2025 — CDMO Opportunities And Threats Report 3/7/2025

    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.

  10. Challenges In Manufacturing TIL For Clinical Trials 3/6/2025

    Tumor-infiltrating lymphocyte cell therapy shows promise for treating solid tumors, but its complex manufacturing profile brings a unique set of issues. Here are some things to watch out for.