Industry Insights

  1. Emerging Technologies In Aseptic Processing: Hype Vs. Operational Reality 6/8/2026

    Let's debunk the misconception that robotics, gloveless systems, or fully closed isolators automatically result in Annex 1 compliance for cell and gene therapies.

  2. Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation 6/8/2026

    Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities.

  3. A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis 6/5/2026

    This is the first published application of data envelopment analysis to six major pharmaceutical analytical validation guidelines, including ICH Q2(R2), USP, ChP, and Brazil's ANVISA.

  4. Inside AstraZeneca's Fully Electrified Cell Therapy Facility 6/5/2026

    The company won an ISPE FOYA for its Rockville, Maryland, manufacturing site that boasts 100% uptime and flexible capacity to produce thousands of batches annually.

  5. AI Has Arrived In Biotech CMC Amid Patchwork Governance 6/3/2026

    AI is surfacing within regulatory and CMC workflows at a vigorous pace. Unfortunately, in small and midsize biotechs, it's happening faster than governance can keep up.

  6. Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT 6/2/2026

    Gene therapy’s next test is not proving it works, but proving it can scale.

  7. CDMO Selection: Start With The Relationship, Not The RFP 6/1/2026

    Friction often comes from unspoken expectations. Before production begins, treat the combined sponsor-CDMO group as one extended team and intentionally make “how we work together” visible.

  8. Why FAT Should Confirm Alignment, Not Reveal Its Absence 6/1/2026

    In many aseptic fill/finish projects, the factory acceptance test (FAT) has become the first true integration test of the entire project. That is a problem. Here's how to flip that mindset.

  9. Managing Supply Disruptions In ATIMP Clinical Trials 6/1/2026

    ATIMP trials leave little room for error. Learn how teams use contingency planning, real-time data, and AI to prevent supply disruptions.

  10. Why Cell And Gene Therapy Has Not Reached More Patients — And Why Clinical Operations Is The Bridge 5/29/2026