GUEST COLUMNISTS

• When Lyophilization Fails At Scale, First Scrutinize Your Formulation

  When lyophilizing a challenging biologic drug product, use an integrated approach optimizing formulation and process parameters together.

• The 5 Shifts That Could Remake Lyophilization By 2040

  Purdue University-based LyoHUB charts a risk-based course to modernizing freeze-drying technology for better performance and advanced modalities.

• Your 7 Decisions To Make Before MES Configuration

  Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.

• DEA Reveals Hidden Costs Of Analytical Validation Guidelines

  By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.

• Qualification And Validation Of Depyrogenation Tunnels And Autoclaves

  Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization. 

• FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters

  The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.

• You Can't CAPA What You Can't Classify

  An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.