Biotech Values

[dewophile]

first off thanks for the link - i haven't read it yet but plan to

as for compaxone - while "no 2 molecules are identical", the final product obviously has some consistent batch to batch efficacy, so there must be some parameters within which the various ratios/sequences/number of peptides fall. so proving sameness entails proving that your manufacturing process results in the same (or less) degree of variability in the end product to the original. i have to think MNTA has looked at many many lots of copaxone - applied their characterization technology to assess how each lot varies from one to the next - to the point where they know these parameters, and reverse engineered a manufacturing process that yeilds an end product that is indistinguishible from the branded product insofar as the variability batch to batch is identical (i.e. no batch falls outside these parameters that in essence "define" the product)
the same holds true for lovenox, another product comprised of a mixture in which no 2 batches are identical