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QbD for Biopharm

Biopharm is one of the most complex manufacturing processes that involves biology, chemistry and engineering to pull off. It is one of the most exciting areas in the space and this lecture helps cover that content. Here is one hypothetical use case that has been developed for reference.

Lecture is here:

1 - A-Mab Case Study

A-mab case study was conducted as a ficticious ‘a-mab’ and help contextualize how one would approach Quality by Design for a Mab product. Here is one hypothetical use case that has been developed for reference.