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Tuesday, July 07, 2020 2:54:50 AM
1)Switching a bioreactor from one mab to another almost never calls for new capital equipment. Contract manufacturers of mabs - like Samsung - couldn't exist if it did.
2)The special sauce (place where things can go wrong) is almost entirely in the scale-up (1L -> 4L -> 16L -> 64L in my day) portion of the grow. That's where unique tricks might be required, and the operator training is most demanding.
3) The big, expensive tanks for volume production operate with processes that are typically independent of mab, except for simple parameter changes. Low training (by FDA standards), low risk.
4)It's entirely possible to have Samsung replicate the scale-up labs without requiring retraining/certifying, making lots of slurry to send to multiple plants, where only the "big grow" tanks and related workers would need to be certified.
Of course we might need a leader to invoke the defense production act to claim the big tanks, but that's another story.
These points make sense at least as of 20 years ago, the last time I worked in a biotech that brewed it own mabs.
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