Quality by design (QbD) principles are increasingly being employed during design and development of manufacturing processes to gain enhanced product and process understanding and to ensure that the commercial manufacturing process delivers product with a predefined quality.  Implementation of QbD principles requires defining acceptable ranges for product's critical quality attributes (CQAs) and performing process characterization studies to determine acceptable process parameter ranges that ensure that the CQA acceptable ranges are met.  The acceptable process parameter ranges are implemented using  'process-wide design space' which is defined by ICH guidance Q8(R2) as �the multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality�. This talk will focus on inclusion of process parameters in the downstream process design space, which provide maximum value with respect to manufacturing site-transfers and operational flexibility.  A 'limited design space' with a small set of process parameters can provide significant manufacturing value with minimal additional experimental investment over a traditional regulatory filing and can simplify health authority review and approval.

Evaluation of a "limited design space" for biopharmaceuticals

247th National Meeting (2014)

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