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Posted On: 04/29/2020 12:50:20 AM
Post# of 153908
Re: chazzledazzle #30607
“the question was does anybody have any ideas about ramping up production with new, scalable bio pharmaceutical technologies.”
There has been no indication from NP or from anyone at CYDY that they’ll use a company either than Samsung or the smaller company in Washington to manufacture leronlimab in the short term.
The BLA was submitted yesterday, which included the Chemistry, Manufacturing, and Controls (CMC) section. This section is important and has proven to delay other biotech’s drugs up to a year while corrections are made. If CYDY were to explore a separate manufacturer or manufacturing process, I’m assuming they’d have to submit a new CMC for the new manufacturer(s). The CMC portion is extensive and expensive to develop, so I don’t expect CYDY to do it in the near future or even the next couple of years.
There has been no indication from NP or from anyone at CYDY that they’ll use a company either than Samsung or the smaller company in Washington to manufacture leronlimab in the short term.
The BLA was submitted yesterday, which included the Chemistry, Manufacturing, and Controls (CMC) section. This section is important and has proven to delay other biotech’s drugs up to a year while corrections are made. If CYDY were to explore a separate manufacturer or manufacturing process, I’m assuming they’d have to submit a new CMC for the new manufacturer(s). The CMC portion is extensive and expensive to develop, so I don’t expect CYDY to do it in the near future or even the next couple of years.
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