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Re: Nanotoday post# 77292

Wednesday, 12/04/2013 2:49:00 AM

Wednesday, December 04, 2013 2:49:00 AM

Post# of 146240
GLP material can be used up to Phase 1 trials. GLP can be made to GLP-like material standards. Scale-up in existing lab space includes specialized larger lab equipment capable of producing 1 kg batches rather than 10 gram (might be a little larger than that). That's two orders of magnatude larger and the new pilot facility I understand will 5 times the retooled space (possibly 10).

At 10-20 gm batches it took a long time to manufactured enough material for maximum feasable dose studies as well as reach an LD10 standard. That's enough material to blow up 1 in ten mice in the test group.

I might be wrong or misremember, but I recall 3 days per batch (though might be 5 including cleaning and prep time between batches) in a quasi-assembly line of mixing and cooking. Anyone who followed Breaking Bad has an idea of the sort of larger scale apparatus that will eventually be in place in the new lab, and an idea of the smaller scale in the current space if one recalls the equipment in that first mobile lab.


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