Industry Insights

1. 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.

    

2. 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.

3. Precigen Secures FDA Approval For PAPZIMEOS And Redefines RRP Treatment 8/27/2025

   Precigen has received FDA approval for PAPZIMEOS, the first therapy for recurrent respiratory papillomatosis, marking a major advance in patient care.

4. Navigating Regulatory Complexity In Cell And Gene Therapy 8/26/2025

   This is a recap of the first three episodes of FDA Fridays, a special four-week series from Cell & Gene: The Podcast. These conversations shed light on the current challenges, best practices, and forward-looking strategies shaping the CGT regulatory environment.

5. 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.

6. Case Studies: Is AI Making Biologics And CGT Outsourcing Smarter? 8/20/2025

   This continues our discussion of AI and CDMOs, focusing on biologics and cell and gene therapy (CGT) relationships. Outsourced Pharma Board Member Vadim

7. Developing Interleukin-2 For Cell Therapies: Key Considerations 8/20/2025

   By promoting cell expansion, survival, and functionality, interleukins help optimize therapeutic outcomes in cancer immunotherapy and regenerative medicine. Let’s look closer and compare ex vivo and in vivo approaches.

8. 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.

9. 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.

10. Lean Manufacturing Implementation In Pharmaceutical Injectable Facilities 8/12/2025

    This comprehensive analysis examines lean manufacturing implementation challenges and evidence-based solutions derived from leading pharmaceutical organizations.