Guest Columns & From The Editor

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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. 

  9. AI-Enhanced Clinical Project Management For Cell And Gene Therapy Clinical Trials 8/12/2025

    Consultant Jessica Cordes explores two of the most critical uses of AI for cell and gene therapy clinical trials: real-time patient journey coordination and predictive enrollment. 

  10. July 2025 — CDMO Opportunities And Threats Report 8/11/2025

    Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.