Industry Insights

  1. Selecting The Right eQMS To Maximize Quality Maturity 4/23/2026

    Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement.

  2. How AI Could Clear Logistics Roadblocks Limiting Patient Access To CGT 4/23/2026

    Patient access often gets mischaracterized solely as a cost and pricing issue. A discussion among industry leaders reaches a deeper, more complex conclusion.

  3. FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing 4/22/2026

    The warning letter, issued to Purolea Cosmetics Lab, describes a manufacturer that used AI agents to generate drug product specifications and more. Here's why the outsourced pharma industry should take note.

  4. Validating Candel's BLA-Ready Analytics Profile 4/22/2026

    The adenovirus/prodrug company discusses in-house assay development and the validation work to confirm CQAs like potency and cell line integrity.

  5. Mapping Candel Therapeutics' Sprint To The BLA Finish Line 4/22/2026

    Leaders from the adenovirus/prodrug developer discuss the complex balancing act of preparing to scale up for commercial manufacturing without overextension.

  6. Why Cell And Gene Therapies Break After Early Success 4/22/2026

    The field has largely solved how to trigger biology, and yet, many programs still fail because what happens cannot be sustained, controlled, or directed over time.

  7. AI, Digitalization, And In Vivo Programming Redefine Cell And Gene Therapy 4/20/2026

    By merging precision genetic engineering with the scalability of nanomedicine and the predictive power of AI, scientists are reshaping the future of human health.

  8. Lilly's Unified Mindset For A Global Parenteral and Device Manufacturing Network 4/17/2026

    Eli Lilly and Company's one-team mindset aims to templatize facility design while remaining nimble enough to react to new manufacturing breakthroughs.

  9. Reprogramming T-Cell Access To Solid Tumors Through Improved Trafficking And Entry 4/17/2026

    Here's why trafficking and entry remain key barriers to CAR T success in solid tumors.

  10. Why A Cell Therapy CEO Waited Until Phase III To Outsource 4/16/2026

    Sometimes, you have to go it alone. For a while, at least. The mantra across biotech has long been clear: engage your CDMO early, and let those experts guide you into manufacturing. Matthieu de Kalbermatten, CEO of CellProthera, a regenerative cell-therapy developer, begs to differ.