Biotech Values

[dewophile]

"..the generic product be chemically identical to the branded product, and MNTA contends that it is.


and the FDA contends that it may not be, or else why require immunogenicity studies. perhaps someone with knowledge in carbohydrate analysis can chime in, but my rudimentary understanding is that such analyses are very complex. you can assess MW, pH, composition of sugars, get some idea of branching patterns, but to actually PROVE the 3-D conformation is identical may not be so easy - and we know that it is this very conformation that may influence epitope recognition by the immune system