Guest Columns

  1. FDA Report Details FY24 Inspections, Shows Big Uptick In Key Countries 8/29/2025

    The 2024 Report on the State of Pharmaceutical Quality shows the agency's efforts to normalize post-pandemic oversight under the previous administration.

  2. Unpacking Pfizer's Advanced Process Control Platform For Upstream Ops 8/29/2025

    Pfizer's advanced process control platform gives modelers more dexterity compared to default controllers, thus speeding up process development.

  3. The OBBBA: Biopharmas Unlock R&D Expensing, Global Tax Efficiencies 8/28/2025

    Biopharma innovators may soon see major tax breaks thanks to the One Big Beautiful Bill Act (OBBBA). The new legislation introduces targeted tax incentives designed to strengthen domestic R&D and capital investment.

  4. New FDA White Paper Ties Quality To Financial Benefits 8/26/2025

    The agency presents as a stepwise approach in which companies can make incremental investments rather than committing large amounts of capital upfront.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. How CZ Biohub's AI Agents Might Assist Drug Developers Beyond R&D 8/15/2025

    Researchers at Stanford and the Chan Zuckerberg Biohub San Francisco developed an open-source platform of virtual researchers who talk to each other.

  10. 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.