Sunday, June 08, 2025 3:42:00 PM
Out of curiosity if you know, when could the first of these systems been purchased. I very much doubt if anything existed back when the Phase 3 trial began, the question would have been, could such units have been integrated into a trial in the middle of the trial. I suspect that the same sort of comparability testing would have been needed that's being done with the EDEN.
Another interesting question might be, is UCLA, who has their own name for the vaccine made at UCLA, using such a device, or do they too make all vaccine manually.
I frankly know nothing about other efforts in this field. Have most companies selected one of these systems to make their products with, so all new products are made with such equipment from the beginning, or are new products still developed with manual techniques, then converted to automation when determined to have commercial potential. It wouldn't surprise me if Phase 1/2 production was manual, but all of Phase 3 was done with the same equipment that will be used for commercial production and the regulators would have no problem with comparability between Phase 2 and 3.
Gary
Another interesting question might be, is UCLA, who has their own name for the vaccine made at UCLA, using such a device, or do they too make all vaccine manually.
I frankly know nothing about other efforts in this field. Have most companies selected one of these systems to make their products with, so all new products are made with such equipment from the beginning, or are new products still developed with manual techniques, then converted to automation when determined to have commercial potential. It wouldn't surprise me if Phase 1/2 production was manual, but all of Phase 3 was done with the same equipment that will be used for commercial production and the regulators would have no problem with comparability between Phase 2 and 3.
Gary
Bullish
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