Biotech Values

[iwfal]

As you're developing a process for production, HPLC or CE analyses at a given step should provide the same trace from batch to batch as evidence of reproducibility. If, in the development process, you've already determined what each of the individual peaks are from a given HPLC / CE analysis (through NMR), then I think it reasonable to suggest that in subsequent batches that you can know definitively what each peak is without having to individually re-analyze them.

Thanks. This is a very cogent explanation of what I was trying to say. That someone skilled in the art would know immediately how to implement what is in the patent - I.e. The patent is fully enabled.

Questions (if I may):

1) What is the chance that one peak in a CE graph ends up a part of multiple different peaks in an HPLC curve? And, if it can map to multiple peaks, how hard would it be to do the mapping?

2) Is there any way to do NMR on an unseparated mixture and see the signature of a particular component in an identifiable way? (Amphastars claim is that it is not possible because all the different components of the mixture interfere with each other - but I doubt the veracity of Amphastar's argument because, for instance, spectrographs accomplish such measurements all the time on heterogeneous mixtures.)