Biotech Values

[dewophile]

MNTA and immunogenicity

I have not followed this story closely, but let me just say that IF MNTA didn't include careful immunogenicity screening in their studies they totally dropped the ball. Not only is it theoretically plausible that changes in sugar moities can result in an immune response, but there is hard data out there that biologics produced via alternate production platforms HAVE induced immune responses SOLELY based on glycosylation patterns (i.e. when the native protein backbone is identical to native protein). that is why GTCB has been meticulous in their immunogenicity studies - NOT just because of theoretical contamination with goat protein, but specifically because of the altered glycosylation. It doesn't matter what "lack of guidance" the FDA gave, they should have planned appropriately if they were messing around and cleaving sugars to try and produce a "biosuperior" or "bioequivalent" (which is what I think their platform entails if I am not mistaken)