by Oliver Yu
A misnomer. I can see how they got that name... from "Pest Control," but I still hate it.
"Bioreactor control" makes sense as cell culture manufacturers try to direct the behavior of pH, dissolved oxygen, temperature, agitation, pressure...
But "contamination control"? No one is trying to direct the behavior of bioreactor contamination: Everyone tries to abolish bioreactor contaminations.
The abolition of bioreactor contamination in a large-scale setting is generally a team sport. It can take just one person to solve the contamination. But usually, the person who figures out what went wrong (the brains) is unlikely the same as the person who implements the fix (the hands). And in a GMP environment, the change implementation is a coordinated process involving many minds, personalities, and motivations. With all those people come an inordinate amount of politics for a goal that everyone seems to want to reach: no contams.
Immediate-/Medium-term FixesThe first thing to realize is that operations management is usually the customer when it comes to solving bioreactor contaminations. Everyone's butt is on the line, but no group burns more resources responding to bioreactor contaminations than them. And in my experience, there is no "short-term" vs. "long-term" solution.
To operations management, there's just immediate solution and medium-term solution.
- Immediate solution :: what are you going to do for me today?
- Medium-term solution :: what lasting solution are you going to implement after the immediate solution?
Science... if it fitsThe second thing to realize is that there's no room for science. The prime objective is to stop the contaminations. The secondary objective is to find the root cause. If identifying the root cause helps stop the contamination, that's a bonus; but root cause or not, you still must stop the contaminations.
For example, if your contamination investigation team thinks that there are five contamination risks, the directive from management will be to implement all CAPAs necessary to address all five risks. If the fixes work, "Great! You met the objective." Do you know what the true root cause was? Not a clue (it was one of those five, but you'll never know which one).
PoliticalThe third thing to realize is that contamination response is as much political as it is technical.
- You can have the right solution, but present it the wrong way - and it's the wrong solution.
- You can formulate the right solution that is not immediately actionable, no one wants to hear about it.
- You can irrefutably identify the true root cause (thereby shining light on GMP deficiencies), and run against resistance.
Being right is different than being effective. And "bioreactor contamination control" at large-scale requires effectiveness. For in-house resources, it requires a keen understanding of interpersonal dynamics. For organizations that are at either a technical or political impasse, there are external bioreactor consultants who understand how to effectively troubleshoot and abolish bioreactor contaminations.
Abolish Bioreactor Contaminations