Sunday, January 22, 2017 8:26:43 PM
"Simultaneously, weare already studying large scale synthesis of the nanomicelle polymer
backbones as well as the short-listed ligands against HSV and VZV, which should provide us a
head-start when we select the clinical candidate. We have scaled up many of the steps in the
production to ~200g to ~500g scales. Our scale up lab and manufacturing facility are well
equipped with reactor systems from as little as 500ml to as large as 30L already. We believe that
approximately 200g production batch size should be sufficient for the Safety/Tox Study batch as
well as for the Phase I and Phase II human clinical trials drug batches. We will need to
successfully produce at least two batches that meet our quality assurance criteria before we can
produce a clinical product batch."
I can never tell whether their batch sizes refer to the basic nanomicelle or the finished drugs. I shouldn't think that they would need 200g batches of individual drugs for testing...that seems obvious...but could they really STILL be referring to the basic nanomicelle here?:
"We have scaled up many of the steps in the
production to ~200g to ~500g scales."
No real need to respond. It's only curiosity on my part. I'm just amazed that I'm still confused by the same things that confused me a couple of years ago.
‘There are none so blind as those who will not see. The most deluded people are those who choose to ignore what they already know.’
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