In the Quality by Design (QbD) framework there is increased expectation of robust characterization of manufacturing processes. At Genentech, we are adopting sound risk-based approaches that leverage mechanistic understanding of unit operations and experimental designs to identify the relevant design space. We present an application of the above methodology to technology transfer of a liquid and a lyo monoclonal antibody formulation to a new drug product manufacturing facility.  The approach enables identification of robust design space and excursion spaces for the relevant unit operations.

Technology transfer to a new drug product manufacturing facility: A case study in quality by design

241st National Meeting (2011)

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