Lessons from Industrial Biotechnology | #2 Scale-up starts on Day One.

When people think about scale-up, they often imagine a larger fermenter: a 100 L reactor. A 1,000 L pilot plant. Or eventually a 100,000 L production facility.
But after years working in industrial biotechnology, I’ve come to a different conclusion.
Scale-up doesn’t begin when you leave the laboratory. It begins when you design your very first experiment. Every early decision shapes what becomes possible later.
– Which host organism do you choose?
– Which analytical method do you rely on?
– How complex is your purification strategy?
– Can the raw materials be sourced consistently?
– Will the process remain economically viable at an industrial scale?

Many promising technologies don’t fail because the biology doesn’t work. They fail because lab success isn’t designed to translate to manufacturing success.
One lesson I’ve learned is that every experiment should answer two questions instead of one:
“Does it work?”
and
“Could this realistically work at scale?”

That second question changes everything. It influences experimental design, process development, downstream strategy, regulatory planning, and ultimately the economics of the entire project. In industrial biotechnology, scale-up is not the last phase of development. It is a design principle from Day One.

I’m curious to hear your perspective:
At what stage do you think teams should start thinking about scale-up?

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