Industry Insights

31. 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.

32. 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.

33. 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.

34. 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.

35. 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.

36. 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.

37. 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.

38. Field Notes: APEC RHSC's Workshop On ATMP Development And Evaluation 4/15/2026

    Scientific and regulatory leaders in the Asia-Pacific region met recently for an exchange of strategies to strengthen convergence and technical competence.

39. U.S. Pharma Tariffs And MFN Become Law After April 2 Update 4/15/2026

    Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.

40. How To Implement Post-Approval Changes On A Global Level 4/14/2026

    To prepare for inevitable process changes after market authorization, this overview provides critical planning advice for assessing risk and minimizing delays.