GUEST COLUMNISTS

• What To Know About — And How To Apply For — FDA's PreCheck Pilot

  FDA has now provided specific eligibility and selection criteria for the PreCheck Pilot Program and a timeline for next steps.

• MES Is Still In The CD ROM Era But The Data Architecture Has Moved On

  Many manufacturing execution system (MES) deployments still operate like it is 2005: a big install, disruptive upgrades, etc. Here's a clearer path forward.

• A Novel In Vitro Glycosylation Approach For Difficult PTMs

  Post-translational modifications of membrane proteins have been historically challenging. Research shows how an in vitro approach brings stability and predictability.

• Field Notes: Reducing Risk At Kivi Bio's Interchangeability Conference

  Risk and fitness for use of interchangeable single-use parts were key themes at the conference. The event exposed communication gaps between suppliers and end-users.

• Using Carbon Nanotubes To Pinpoint Optimal Harvest Time in Bioprocessing

  Cell-free expression systems confound the moment of peak expression. These nanosensors signal through crude lysate for process optimization and endpoint monitoring.

• 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."