QbD Approaches in Cell Culture Process Development
Alain Bernard, Vice President, UCB Pharma SA
Using as
a model a typical recombinant therapeutic antibody process we will discuss strategies
and approaches to designing and developing manufacturing processes that ensure
optimal quality of the process and the product once they are used commercially for
the market. We will
report how process development space was defined, mainly based on a rigorous risk
analysis. The resulting science-based manufacturing process will be submitted
to authorities with experimental data demonstrating our in-depth understanding
and control over the various process parameters and how they may affect product
critical quality attributes. This work was done in parallel and without any
negative impact on the clinical material manufacturing.
The
data were collected using a scale-down model of the commercial manufacturing
infrastructure and supported a complete process characterization. In turn, this
enabled a very successful validation campaign at full scale with a model that
was shown to be a good representation of the large scale equipment and
environment. The remaining open issues and outcom
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