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Field notes from the plant floor

Practical writing on running bioprocess and device manufacturing, grouped by the three areas where programs most often stall.

Contamination and sterility

We Know a Lot About Bacteria, So Why Does Biofilm Matter?
If the control strategy is to kill everything, why does biofilm matter? Because the survivors are the ones you can't detect.

Biofilm and Dry Surface Contamination in Bioprocess Manufacturing
Slow-growing contamination that standard surveillance misses, and what it does to a clinical timeline.

Facilities and infrastructure

Case Study: Operational Excellence in Bioprocess Manufacturing
A preclinical program's quality decline, traced to cold-storage practices nobody was watching.

Alarm Strategy for Temperature Controlled Units in Bioprocess Manufacturing
Setting limits is the easy part. Agreeing who responds, and how, is the hard part.

Power Matters — Use the Right Outlet or Add Risk to Your Process
Matching critical equipment to the right power source: UPS, generator or grid.

Operations and strategy

Case Study: Workflow Optimization
Load leveling across five production lines raised deviation-free yield 5x without adding headcount.

Bioprocess Manufacturing and Better Faster Cheaper Mentality
Why scale-up and cost decisions belong in Phase I, not Phase III.

Slower is Faster
Balancing aggressive timelines against reproducible scale-up.

Is Your Quality System Pushing Your Team Around?
When a quality system outgrows the process it was built for, and how to rebuild it.

Phase Appropriate GMP and Small Entity Compliance in Bioprocess Development
Matching the level of control to the development stage.

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