Implementation of Quality by Design (QbD) approaches have gained acceptance in the biotech industry in recent years. This case study presents a stepwise approach for defining the design space for a downstream process of a recombinant enzyme.  A complex non-chromatographic unit operation was part of the downstream process for the studied molecule.  This imposed unique challenges compared to design space studies for other biologics with well-established chromatography steps. Prior knowledge and early development experience was used to identify key parameters and attributes required for process characterization studies.  The extensive prior process experience reduced the amount of process optimization studies required for the downstream process.  A high throughput small scale model was developed and employed for the DOE studies, thus resulting in accelerated process development. A multivariate design of experiments (DOE) approach was used as part of the screening studies to identify parameter interactions and define acceptable operating ranges. This case study demonstrates the successful implementation of QbD to study the downstream process design space for a recombinant enzyme.

Implementation of quality by design (QbD) principles for enzyme biotherapeutics: A case study

247th National Meeting (2014)

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