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Posted On: 08/15/2020 1:07:04 PM
Post# of 148936
I'm pretty sure if a EUA were issued that there would be a run on the available leronlimab to the point I feel government would step in to "provide fairness" at distribution.
Earlier in the summer there was talk of 1.2M vials being delivered in 2020. Then later it was 1.5M. Maybe they included what was in inventory that was still viable into the latter figure.
At 4 doses per patient, that would allow for 375,000 patients.
Two big things about getting a new facility ramped up for production are 1) Tech transfer and training; and, 2) Getting FDA approval for that facility to manufacture that biologic.
I found this article very informative as it relates to COVID and mAb development, testing, and production:
https://www.nature.com/articles/s41587-020-0512-5
Section 7 discusses production:
https://www.nature.com/articles/s41587-020-0512-5#Sec7
Earlier in the summer there was talk of 1.2M vials being delivered in 2020. Then later it was 1.5M. Maybe they included what was in inventory that was still viable into the latter figure.
At 4 doses per patient, that would allow for 375,000 patients.
Two big things about getting a new facility ramped up for production are 1) Tech transfer and training; and, 2) Getting FDA approval for that facility to manufacture that biologic.
I found this article very informative as it relates to COVID and mAb development, testing, and production:
https://www.nature.com/articles/s41587-020-0512-5
Section 7 discusses production:
https://www.nature.com/articles/s41587-020-0512-5#Sec7
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