GUEST COLUMNISTS

• New Guide Aims To Build Robust Framework For Digital Validation Tools

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

• Pfizer's Accord For A Healthier World Program Challenges Stability Study Norms

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

• Takeda Reimagines Biopharma Quality For The Digital Age

  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.

• 100% U.S. Drug Tariffs: Implications For Pharma And Outsourcing

  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.

• Should We Refocus On The Product, Then Engineer The Process?

  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.

• Risk-Based Analytical Method Selection In Cleaning Validation Using ASTM International Standards

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

• What Can The Tech Sector's 'Minimally Viable' Concept Teach Biopharma?

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