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Not sure there is much the government can do in th

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Post# of 155052
(Total Views: 576)
Posted On: 04/04/2020 10:53:59 AM
Posted By: OTCnewbie
Re: Northstar42 #25388
Not sure there is much the government can do in the immediate future about capacity, that is up to ACG and Samsung (I’m sure the US government can lean on them to increase their output). Im sure they will be more than happy to oblige anyway. But commissioning a new manufacturing facility outside of those two companies normally takes a full year, and that is at an industry leading pace (this is what I do for a living). Remove some red tape and I’m sure this could be sped up. Normally the FDA requires 3 successful runs (fully documented) lasting a 1-2 months EACH, not including multiple trail runs, quality testing, the initial knowledge transfer, and likely some facility tweaking. When I started doing this, the process would take 18-24 months, so a lot of optimization has already happened. 6-9 months would probably be best case scenario for adding any new manufacturers. Not all Leronlimab is created equal if manufactured incorrectly. Mabs are extremely, complex molecules. Quality attributes and therefore efficacy, stability etc are impacted by as little as a change in one degree in process temperature or minor changes in pH or a dozen other controlled conditions.


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