Why ‘purity’ issues? | NVAX Message Board Posts




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Msg  146293 of 154364  at  10/20/2021 8:13:25 AM  by

muddyc


 In response to msg 146268 by  BillyT
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Re: Why ‘purity’ issues?

I just dont follow this story well enough any more, so I cant say. Absolute purity aside (vs. either bad spikes or Sf9 guts), one would expect potency assays (which would compensate for dead material) would determine the fill for use material. Not only do I not follow it, I dont know shit about vaccine QC. I can suppose the things I would want to know. Just messign around in my basement prepping diatoms and eating cheetos, I would lean heavy into a potency assay. Obviously it appears the FDA and others want a lot more characterization of particles e.g. (something I would have thought of as more academic). Looking at the wyatt that red mentioned and, well, hell yes, why not. Pretty cool toy. I suppose one could assume some sort of DLS would be part of this. But now it has come back to the issue of purity. I have always been amazed their process works at scale. So ... does it work at scale?


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