Featured Editorial

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. Do Changes Signal The End Of Biosimilar Regulatory Redundancy? 4/23/2026

   First came excitement over the looming patent cliff. Then, FDA and EMA took big swings at what many have called redundant work. Combined, they make a more attractive environment for biosimilar developers.

3. 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.

4. 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.

5. 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.

6. 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.

7. Expanding The IV → SC Framework: What Reformulation Really Means 4/22/2026

   IV → SC is a system design challenge. Success depends on aligning formulation, device, manufacturing, and clinical strategy early to avoid costly failures and redesigns.

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. 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.

10. 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.