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dewophile

08/02/10 7:36 PM

#100482 RE: rkrw #100481

mnta

If the manufacturing process is fixed, why should there be any greater inherent variation for Sanofi than Momenta?



because MNTA's manufacturing process had to result in product that fell within the parameters of that of SNY's (and i am sure they analyzed many batches to establish this range), so it follows that MNTA's manufacturing must result in product with variation no more than that of SNY's, but quite likely less than that of SNY's
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zipjet

08/02/10 8:12 PM

#100484 RE: rkrw #100481

If the manufacturing process is fixed, why should there be any greater inherent variation for Sanofi than Momenta?



In the Sandoz process, it is not fixed. In fact, the analytics are embedded in the manufacturing process. This allows Sandoz to adjust for inconsistent feed stocks that cause higher variation in output for SNY.

Pretty cool.

ij