Typically, each one of the batches is tested prior to putting it into the pool. It also can depend on
the nature of the process and use of the Intermediate. If you are talking about Intermediates that
are going to be prepared, and then blended after a period of storage, that might lead you to a test
and pool control system. But, if you are running multiple aliquots of a harvest across a purification
column sequentially within a small period of time, and then pooling all of these aliquots, individual
testing of aliquots that may not require individual testing of each aliquot. But, it might also be a
good idea to have a look at each of the individual aliquots, at least once or so, to make sure that
they’re more or less the same. But, that would not require individual testing and confirmation each
time.
One of the issues that you get into, and this sort of drifts over into the filing issue, is what defines
a lot or batch. Certainly, if you’ve got a fermentation process that is relatively short, and you can
do three in a week and then pool them. This might however be different than, say, one of the
batch re-feed systems that goes on for up to six months. The batch dynamic is going to be
different, and how you would test and how you would characterize each individual harvest as
opposed to each individual “pool” might be different.
