Guest Columns

1. Dual Membrane Preconditioning Can Improve Concentration, Cut HCPs 10/27/2025

   Research from Penn State, the FDA, and Takeda shows how combination filtration and purification steps improve output and reduce impurities.

2. New Guide Aims To Build Robust Framework For Digital Validation Tools 10/22/2025

   The ISPE's new guide addresses software for managing digital assets related to qualification, verification, validation, and compliance assurance.

3. Pfizer's Accord For A Healthier World Program Challenges Stability Study Norms 10/22/2025

   The company developed a novel approach to address the historic lack of stability testing for underserved parts of the world, near the equator.

4. Takeda Reimagines Biopharma Quality For The Digital Age 10/21/2025

   Artificial intelligence, even in its current form, is especially good at synthesizing large data sets. Here's how one company makes the most of it.

5. 100% U.S. Drug Tariffs: Implications For Pharma And Outsourcing 10/17/2025

   Research Manager Mathini Ilancheran explores the effects of U.S. drug tariffs on global supply chains, multinational pharma firms, and critical partners across drug development.

6. Should We Refocus On The Product, Then Engineer The Process? 10/14/2025

   Logic behind the "process is the product" refrain collapses when you accept that starting material is non-uniform by design. These experts want to rethink a tired cliche.

7. Risk-Based Analytical Method Selection In Cleaning Validation Using ASTM International Standards 10/14/2025

   This in-depth article describes risk in cleaning and provides a science- and risk-based framework for selecting analytical methods using ASTM International standards.

8. What Can The Tech Sector's 'Minimally Viable' Concept Teach Biopharma? 10/9/2025

   Deciding what is good enough to get started can support the mindset of building something without sacrificing quality, functionality, or safety.

9. Fermentation Of Live Biotherapeutic Products In cGMP Environments 10/8/2025

   We follow the journey from master cell bank to large-scale anaerobic fermentation, highlighting the unique needs for working with oxygen-sensitive, strictly anaerobic therapeutic microbes in a cGMP setting. 

10. Import Product Specifications And Drug Registration Testing For China 10/6/2025

    This overview and its recommendations are valid for drug registration testing (for marketing authorization application in China) as well as import testing (for commercial batches to be imported to China after approval).