Abstract

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