i guess what i found disappointing (and surprising) when i learned amphastar met the 5 criteria years ago is that wheeler was asked at the Q2 cc if based on techniques in the literature* one can meet the criteria and he said NO flat out - that one would have to develop unique tools. so meeting the 5 criteria is a wall that i thought would stand for some time
Just talking it through:
I agree that the revelation that the 5 criteria (in some form) existed 5+ years ago was a significant disappointment - but offsetting that IMO was the fact that they 'met sameness' 5 years ago and yet are still not approved.
As for Wheeler's comment - I don't think it is wrong. But with the board's previous understanding of what 'the 5 criteria' meant we would interpret it incorrectly. Clearly the 5 criteria have evolved at the practical level (probably due to the biologics area getting involved) - and at the level that existed as of, say, 1 year ago (vs 5 years ago) I suspect that he was correct.
PS Random thoughts on the process. It would appear that a molecular weight down to about 3500 Daltons may still be acceptable. This is a wider limit than I thought would be acceptable - BUT I would suggest that if that is the weight you are getting for your LMWH then your process is different enough that you are going to produce things not seen in Lovenox. E.g. the g-enox is 20% off on MW, but produces 15 contaminants that are >40x as high as in Lovenox. Or, IOW - it is one thing to require that the overall average be within 20%, but it is a whole different thing to require that each of the pieces be within 20% (or even a factor of 2) and any that are not have to be justified from an immunogenicity viewpoint.
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