Guest Columns

1. 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.

2. 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.

3. 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."

4. 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. 

5. 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.

6. 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.

7. 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.

    

8. 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.

9. 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.

10. 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.