GUEST COLUMNISTS

• New ISPE Framework Targets Uncertainty In Pharma's AI Deployment

  International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.

• Facility Considerations When Retrofitting Legacy Sites For ADCs

  Antibody-drug conjugate manufacturing requires, among other things, unidirectional flow and air locks for people and materials. Facilities often lack these attributes.

• The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing

  The promise of AI is colliding with the harsh reality of data chaos in pharma manufacturing. This article explores why most AI investments fail, and a 5-layer solution.

• Why Use Total Organic Carbon Analysis For Cleaning Validation?

  Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.

• Do's And Don'ts Of Material Handling When Retrofitting For ADCs

  Antibody-drug conjugate manufacturing includes extremely dangerous ingredients, and most legacy facilities lack the features and flows for safe handling.

• Building Enterprise Resilience From QRM Signals

  Turn enterprise resource management (ERM) from a checklist into a true decision system — so risk informs everyday choices before quality events become supply disruptions, delays, or regulatory exposure.

• Single-Use Standards Are Maturing, But The Process Remains King

  The food industry inspired single-use in biopharma, but the regulatory landscape is far more complex. If you're worried about compliance, this discussion can help.