Featured Editorial

1. Minimizing Regulatory Risk For Biologics Manufacturing Changes 4/29/2026

   Any manufacturing process change for a biologic can raise comparability questions. Here’s a practical, action-oriented strategy to ensure health authorities are satisfied.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.