Monday, October 10, 2011 2:52:32 PM
I was encouraged to read that the cGMP system is being built offsite to be delivered to the new location. It means that the cGMP hardware/software is being built to spec. This is an important factoid. The knowledge base for the cide processing formula is either very well understood and mature or simple or both to be able to write a spec to build to. In my view, this bodes well as a sign of low risk to meet the schedule for operation and production of the cGMP facility.
Further benefits of this approach are that production is scalable. Scalable by replication of cGMP designs, or scaled up cGMPs designs by size. This is a big plus if stock piles were requested on short notice. Once on line, the scale of production could be quickly and efficiently ramped up to meet demand.
Furthermore, I would venture to say, and this may never be confirmed due its proprietary nature, that there is very little difference in the cGMP design for Flucide, HIVcide, Denguecide, etc. So, by the next cide through the FDA, the FDA will have already approved the cGMP design and production quality standards for the next cide.
The sequence of events that are lining up is really exciting to me. Comments welcome.
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