Which is why I believe that Northwest Bio won’t go to market without Flaskworks automated manufacturing.
I expected the "we are waiting for Flaskworks" punt to come sometime this winter.
Most here fail to understand an important point.
Biologics are in part defined by the exact process used to grow them. Changes to the process can change the product in unknown ways. And we do not yet have the ability to completely characterize biologics.
So the characterization process is complex. We are talking far more than a SAP here. And likely a clinical trial.
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