GUEST COLUMNISTS

• A Practical Look At Modern Downstream Processing For Biologics

  Part 2 in a series about current bioprocessing practices explores the latest in separation, purification, sterile filtration and aseptic filling.

• Process Engineering's Key Role In Sterile Injectable Facility Design

  Quality requirements for parenteral drugs complicate facility design like few other regulated products. If you're developing injectables, be aware of these key issues.

• 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.