Featured Editorial

1. What 2025 FDA Warning Letters Tell Us About GMP Compliance 12/15/2025

   This analysis identifies key compliance trends and regional disparities by examining the 2025 U.S. FDA warning letters issued to drug product manufacturers posted between Jan. 1 and Dec. 9, 2025.

2. Clinical Supply's Role In Driving Success In Decentralized Trials 12/11/2025

   Decentralized trials are a challenge for supply chain professionals. Explore how logistics, labeling, and home delivery make or break trial outcomes.

3. Phages As A Pharmaceutical: New EMA Guidance On Antimicrobial Drug Development 11/17/2025

   The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products. Rising antimicrobial resistance has renewed interest in bacteriophages to fight pathogens.

4. On The Potency Assurance Journey, Travelers Need A Road Map 11/13/2025

   When regulatory expectations change by the phase, the route can be difficult and confusing to navigate for both new and experienced potency investigators.

5. Guidelines For Defining A Control Strategy Framework For Accelerated mAb Programs 11/6/2025

   This article assembles an industrywide “platform” knowledge base on the impact of parameters across unit operations in a standard mAb process. 

6. A Multi-Omics Approach For Characterizing Clinical-Scale iPSC Batches 11/6/2025

   The transition from 2D to 3D cell culture requires a combination of advanced analytical techniques, but aligning new methods with established principles can be challenging.

7. Global Implications Of Zero Tariffs On Indian Pharma Exports To China 11/5/2025

   Discover the worldwide impacts of China’s zero-tariff policy on Indian pharmaceutical drugs.

8. Why Do So Few Cell Therapies Make The Leap From Lab To GMP? 11/5/2025

   Among other reasons, academic centers have access to sophisticated technology. In contrast, manufacturing suites must use established, validated methods.

9. Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots 10/31/2025

   The terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.

10. Careful Outsourcing Proves Key To Targeted Protein Degradation Drug Development 10/21/2025

    Discover how partnerships — especially with capable CROs — as well as resilient supply chains, digital enablement, regulatory foresight, and specialized talent impact the success of targeted protein degradation therapies.