Featured Editorial

  1. When Single-Use Technology Becomes An Economic Imperative 9/3/2025

    Industry changes increasingly favor SUT for novel products, even while stainless steel remains an essential part of many process trains.

  2. Lilly's Exploring A Universal AAV Purification Method 9/2/2025

    Serotype-specific resins don't scale gracefully. One team at Eli Lilly and Company is exploring an alternative that skips affinity resins altogether.

     

  3. CSL Behring's Robotics Push Is One Of The Biggest We've Seen Yet 9/2/2025

    An expansion project, including an abundance of automation features, at the CSL's Victoria, Australia, campus earned the company an ISPE Facility of the Year Award.

  4. 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.

  5. 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.

  6. 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.

  7. Single-Use Standardization Starts At Home 8/28/2025

    During a Bioprocess Online Live event, “Single-Use Harmonization Needs A Tune Up," panelists discuss a way forward for the industry to unlock the true flexibility and promise of single-use technology.

  8. 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.

  9. Biopharma Manufacturing Outsourcing Is Flexible, Not Fractured 8/21/2025

    An element of the 2025 BioPlan Associates annual report and survey took Chief Editor Louis Garguilo by surprise. The report intimates that biopharmaceutical manufacturing faces a fractured CDMO market. Despite solid data to back that assertion up, Garguilo presents a very different view, one based on what many readers have expressed.

  10. 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.