Are you
a Start-Up?
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Vision: Do you know where your process is headed? Don’t look back and regret earlier decisions – realizing avoidance was possible if only someone had pointed out the now obvious.
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Scale-Up: Moving to the next level does not have to be nerve racking. Know the pitfalls that exist and plan appropriately. I am always amazed at the highly opinionated who have done very little scale-up. There are a few important items, and many that are less important. Know the difference.
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Modeling: Don’t feel bad. I am amazed at the number of companies that put this off. You need a good Techno-Economic Analysis (TEA). What happens if the fermentor is 50m 3 bigger? What’s better: sterilize the fermentor in batch or continuous mode? Any clue just how much water your process uses? Also, a well constructed TEA will feed right into an LCA model.
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Production Location: Engage a CRO now and build later? Let’s discuss production options based on your current and planned process phase.
Is Production Underway?
Need more Product!
Production improvement should be an annual goal – without the addition of more stainless steel. I have designed dozens of processes. Let’s make sure you are not overlooking an easy improvement.
Need to Scale-down?
Yes! Many times I’ve had to step back to move forward. You need a good lab model that predicts the impact of production changes. The model does not need to match exactly, but it must be predictive. Know the difference.
Where to Manufacture?
Running out of production space? Let’s discuss options.
Technology Selection
Which DO/pH/FTIR probe technology is best? Is single-use really worth the cost? Is on-line analysis even practical for my process?
Contamination Control
Let’s face it: like other things in life, contamination happens. Truth is, it should be a rare event.
Learn how to methodically shake down your process and eliminate bad practice and faulty systems. Stop wasting money.
VC and PE:
Buyer Beware:
I’ve heard too many horror stories regarding disappointment after
closing. Let me shake down their claims and give you an outside assessment. The sales pitch is always rosy.
Let’s examine:
-The technology
-Unresolved and future possible issues
-Technical capability (Does it exist? Is it too dependent on a few folks?)
-IP positioning (How much protection does the patent really provide? I’ve worked around many a “restrictive” patent.)
