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Posted On: 07/27/2020 11:35:50 AM
Post# of 148908
Quote:Samsung's website states they currently have 12 trains of 15,000 L capacity between all of their plants.
Thank you, but I dont know what that means. Lol.
In a post back in April, Ohm20 stated:
Quote:I believe there is an FDA restriction that requires qualifying the production of a mAb in different bioreactors / plants, even when they are identically designed, and even when they are owned and operated by the same company. Whether or not that restriction is eased by the FDA in the context of the pandemic is unknown.
In an interview from back in I believe late January, early February, Nader said Samsung was assigning us 8 25KL bioreactors for a 600,000 dose batch. The 25KL must be the total reactor volume with 15KL being the amount of culture medium. I'm not sure what efficiency Samsung has (might be less in larger reactors), AGC claims up to 4.5g per liter. At that efficiency Samsung would produce 771,000 doses at 700mg.
Source Link: https://investorshangout.com/post/view?id=572...z6IfrGm4Qv
In any case, the conversion equation between Liters and Kilograms is as follows:
15,000 L = 15 Kilograms/Liter
So, by extension, the language in that May 2016 10K, implies that FUJIFILM has or had the capacity to produce leronlimab in the thousands of liters (multi-Kg = multi thousands of Liters).
Quote:Of course, who knows if this rumor is true, if CytoDyn still has a working relationship with FUJIFILM, or if FUJIFILM even has the availability.
This contract manufacturer previously produced multi-Kg scale bulk batches of PRO 140 under cGMP for our Phase 2 clinical studies and is capable of producing sufficient quantities of PRO 140 for all the clinical studies required prior to submitting a BLA to the FDA.
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