GUEST COLUMNISTS

• Why Contamination Control By Design Should Matter To Your CDMO

  EU GMP Annex 1 mandates a documented contamination control strategy, and FDA expectations are substantively equivalent. Let's look at why CDMOs are disproportionately exposed.

• Repeating Sanofi's Ballroom Design On Two Continents

  Moveable walls and a stunning number of robotics at its sites in France and Singapore, among other features, has earned Sanofi international recognition for innovation.

• Closing The MES Value Gap: Why Technology Isn't The Problem

  Manufacturing execution system (MES) technical maturity is rising, but adoption across manufacturing sites is uneven. Organizational readiness may hold the key.

• Why Are Life Science Companies So Poorly Prepared For RIM's Future?

  Most organizations have modernized their global regulatory information management (RIM) systems and improved data quality. Yet modernization and readiness are not the same thing.

• CDMO Capacity Crunch: Are Biotechs Wasting Time On The Wrong CDMO?

  Biotechs often default to one of two flawed instincts: pursue the biggest name in the space or go with the lowest bidder. To avoid misalignment, look at these less visible factors.

• Why Your MES RFP Is Failing Before It Starts

  Many manufacturing execution system requests for proposals fail. Not because vendors cannot deliver or the tech is immature, but because the requirements are written backward.

• Why Dilution Gets Tricky: The Role Of Measurement Variability

  Dilution's effects on downstream processes and final formulation is often understated. A statistical framework can quantify measurement uncertainty's impacts.