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Absolutely FG.....having worked in the pharmaceutical industry...

  1. 2,105 Posts.
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    Absolutely FG.....having worked in the pharmaceutical industry in R&D and Regulatory Affairs I know the long risky road from discovery to commercialisation. There is I think more challenge in validating "scaled down products and processes" than what I was used to in going from lab scale up to commercial production scale.

    With my limited expertise, I can't imagine all the dificulties involved in validation of the Mycrolab technology on the way to registration and commercialisation.

    However, many other companies specialising in portable diagnostic systems have already done it successfully for quantitative and qualitative analysis for a hell of a lot of chemical and biological substances in human fluids and gasses. All involve quite sensitive analytical methods which have been shown to be specific, accurate and reproducable on all scales on the way down in size. Most of the onces I can think of have been progressively scaled down radically particularly in the last few years.

    Mycrolab (with this technology) are surely not talking about identifying the presence of the TB organism itself but specific markers of TB infection in blood and as long at is Cellestis's analytical method and not T-Spot that they are able to adapt.

    Of course I know no more that what I read in the paper and on the internet today so my thoughts may be pure fantasy.
 
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