GUEST COLUMNISTS

• A Peek Into Novo Nordisk's Sustainable Facility Construction Mindset

  Fill/finish operations are famously resource-heavy. Nonetheless, Novo set out to achieve ambitious environmental goals with its $4.1 billion project in North Carolina.

• The U.S. Has A New Vice To Squeeze Foreign Imports: Pharma Quality

  The Trump administration has effectively merged national security, trade policy, and drug quality. Now, foreign manufacturers lacking deals face paying a "quality tax."

• This Industrial Fungus Has Protein Expression Promise For Pharma

  Trichoderma reesei is well characterized for industrial uses. A Finnish research group is exploring it for pharmaceutical protein expression.

• Real-World Phase-Appropriate Control Lessons For mAb/ADC Manufacturers

  Effective mAb and ADC manufacturing control strategies evolve through the phases. These four principles should guide your strategy design as goals shift.

• High Specific Productivity For Leaner Sustainable Bioprocessing

  Improving specific productivity moves the goal beyond pumping out higher titers, but it demands a deeper understanding of cellular biology and protein expression.

• 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.