GUEST COLUMNISTS

• An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs?

  FDA’s real-time CRL releases face legal and operational hurdles. Could AI-assisted redaction make transparency faster and more consistent?

• Navigating Outsourced Pharmaceutical Testing Through Today's Geopolitical Uncertainty

  Geopolitical shocks are reshaping outsourced pharmaceutical testing. Learn how procurement teams can strengthen resilience and protect continuity.

• Is Your Supply Chain Ready For The End Of Class VI?

  Revisions to USP <87> and <88> update biological reactivity testing — changes that are especially important for companies that rely on single-use technology.

• 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.