Featured Editorial

1. What Sponsors Must Know About Digital Systems And AI Compliance 7/17/2025

   Consultant Jessica Cordes provides an update on proposed changes to GMP guidance that affect trial conduct, including documentation, computerized systems, and the use of AI.

2. 4 Centralized Comparator Sourcing Models To Fortify Supply Chains 7/15/2025

   A team at Novartis developed models to address the often-overlooked challenge of clinical trial comparator sourcing, a weak link that can derail trials.

3. The New Clinical Packaging Paradigm: Differentiation And Decentralization 7/8/2025

   The rapid evolution toward flexible, decentralized clinical supply models is placing unprecedented strain on traditional clinical packaging organizations. Can traditional models adapt fast enough to stay viable?

4. 7 New MHRA Guidances To Help You With Decentralized Manufacturing For Cell And Gene Therapies 7/3/2025

   The U.K.'s MHRA has followed through on its promise to issue guidances to aid industry in understanding the recent changes to regulations for licensure of medicines employing cell and gene therapy technology.

5. Sorriso's Path To Oral Biologics Dosing Is Through The Gut 6/30/2025

   Following positive results from a Phase 1b trial, company leaders describe scaling their yeast expression and spray-drying processes as they prepare for Phase 2.

6. EMA Guideline On Clinical-Stage ATMPs Comes Into Effect: On The Verge Of Convergence? 6/19/2025

   The EMA’s Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials came into effect on July 1, 2025

7. What Global Survey Says About Scant Patient Access To CAR-T Therapy 6/17/2025

   The Worldwide Network for Blood and Marrow Transplantation initiated a survey to understand cost, infrastructure, and regulatory differences affecting access.

8. Scaling Up Manufacturing? Here's Why You Need A CMC Specialist 6/16/2025

   CMC experts (whether in-house or outsourced) fill a vital role during the transition from small-scale production to larger operations for maintaining quality, consistency, and compliance.

9. Peeling Back The Layers Of Radiolabeled Peptide Production 6/12/2025

   From the moment radiolabeled drugs are made, it’s a race to get them to patients. Radioactive decay is just one of many complications. Here’s one company’s approach.

10. Multispecific Trial Supply Stability Hinges On CDMO Agility 6/10/2025

    Naya's CEO describes the dynamics of producing a complex therapeutic for clinical trials on another continent, and how choice of CDMO plays heavily into that strategy.