GUEST COLUMNISTS

• 5 QMS Blind Spots You Should Know About

  Companies often underestimate the complexity of standing up an eQMS. These are five of the most common issues that lead to regulatory and GMP exposure risk.

• New MIT Consortium Links Innovation With Real-World Biomanufacturing

  In one area, the Initiative for New Manufacturing is exploring whether microfactories, championed by the EV industry, can help biopharma iterate facility design faster.

• The Hidden Engineering Behind Successful Upstream Bioprocessing

  In upstream biopharmaceutical production, manufacturing is inseparable from biology, engineering, contamination control, and quality science.

• 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.