Within the paradigm of Quality by Design (QbD) regulatory agencies are emphasizing classifying process parameters based on quantitative approaches. Here we present a data-driven, quantitative methodology to classify process parameters into critical or key/non-key categories based on the calculated impact on critical quality attributes or process performance respectively. An impact ratio is calculated for process parameters showing statistically significant impact during process characterization experiments. The resulting impact ratio is compared against a pre-defined level to classify the process parameters. The presentation will discuss antibody aggregation as a critical quality attribute and product titer as a performance attribute in a cell culture process.

Quantitative process parameter classification approach for biopharmaceutical development in QbD paradigm

249th National Meeting (2015)

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