Guest Columns
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The Hidden Engineering Behind Successful Upstream Bioprocessing
2/25/2026
In upstream biopharmaceutical production, manufacturing is inseparable from biology, engineering, contamination control, and quality science.
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A Practical Look At Modern Downstream Processing For Biologics
2/25/2026
Part 2 in a series about current bioprocessing practices explores the latest in separation, purification, sterile filtration and aseptic filling.
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Process Engineering's Key Role In Sterile Injectable Facility Design
2/24/2026
Quality requirements for parenteral drugs complicate facility design like few other regulated products. If you're developing injectables, be aware of these key issues.
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What To Know About — And How To Apply For — FDA's PreCheck Pilot
2/23/2026
FDA has now provided specific eligibility and selection criteria for the PreCheck Pilot Program and a timeline for next steps.
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MES Is Still In The CD ROM Era But The Data Architecture Has Moved On
2/20/2026
Many manufacturing execution system (MES) deployments still operate like it is 2005: a big install, disruptive upgrades, etc. Here's a clearer path forward.
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A Novel In Vitro Glycosylation Approach For Difficult PTMs
2/19/2026
Post-translational modifications of membrane proteins have been historically challenging. Research shows how an in vitro approach brings stability and predictability.
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Field Notes: Reducing Risk At Kivi Bio's Interchangeability Conference
2/19/2026
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.
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Using Carbon Nanotubes To Pinpoint Optimal Harvest Time in Bioprocessing
2/18/2026
Cell-free expression systems confound the moment of peak expression. These nanosensors signal through crude lysate for process optimization and endpoint monitoring.
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A Peek Into Novo Nordisk's Sustainable Facility Construction Mindset
2/18/2026
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.
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The U.S. Has A New Vice To Squeeze Foreign Imports: Pharma Quality
2/13/2026
The Trump administration has effectively merged national security, trade policy, and drug quality. Now, foreign manufacturers lacking deals face paying a "quality tax."