Guest Columns

  1. The New FDA Era Of Radical Transparency And Pervasive Oversight 9/9/2025

    The first half of 2025 has been transformative for biopharmaceutical quality and regulatory affairs, with the FDA leading the charge with four significant changes. Curadian Group's David Grote discusses implications for all four.

  2. A Case Study In Continuous Process Verification 9/8/2025

    CPV can strengthen the bridge between compliance and continuous improvement. In this scenario, a hypothetical lab sets out to improve process yields and efficiency.

  3. Optimizing Lentiviral Vectors For Allogeneic CAR-T Manufacturing 9/5/2025

    A group of graduate researchers explored VSV-G affinity chromatography as an alternative to the standard anion exchange chromatography or AEX.

  4. Reliably Predicting Biologics Hotspots From Prior Knowledge 9/5/2025

    Site-specific post translational modifications can seriously affect a molecules stability, function, and structure. These modifications are commonly called "hotspots."

  5. Building The Biopharma Manufacturing Facility Of The Future Requires A Phased IT/OT Strategy 9/4/2025

    Your pharma or biotech company can take these actionable steps to achieve digital facility operations and successfully build your own facility of the future. 

  6. New Group Wants 'Phase-Appropriate' Thinking To Retire 9/4/2025

    Decisions in cell and gene therapy are not about aligning with arbitrary clinical phases but about balancing risk.

  7. 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.

  8. 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.

     

  9. 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.

  10. 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.