Upstream is a chain of transfers, each with criteria that have to be met before the next step starts. Vial thaw, shake flask, rocking bag, N-1, production. The batch record has to show that every transfer criterion was checked, and most of that is a paper form at the bioreactor.

The bioreactor knows everything, DO, pH, temperature, feed events, and the batch record knows almost none of it. In-process samples go to the ViCell and the Cedex and the results come back on a printout, disconnected from the run that produced them.

Labbit enforces stage-gate criteria at every transfer, captures online bioreactor parameters against the batch, integrates cell counters and metabolite analyzers for direct in-process result capture, and tracks cumulative feed genealogy through fed-batch and perfusion.

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