Quality by Design (QbD) is a systematic approach for product development ensuring consistent manufacturing of efficacious and high-quality biopharmaceutical products.<br/>During development activities that follow a QbD methodology, product and process knowledge is built in to establish efficient Control Strategies. Successful Process Performance Qualification confirms that the described Control Strategy is sufficient to consistently manufacture the product of interest according to pre-defined quality. Documented process knowledge that is data driven and based on solid risk management is the foundation for consistent routine manufacturing and continuous improvement.<br/>Only the combination of product and process understanding can effectively govern efforts during process characterization. We have established a series of combined risk evaluation activities that, if applied sequentially, ensure that development work focuses on establishing an optimal Control Strategy for product quality and process consistency. The main steps are: creation of a Quality Target Product Profile (QTPP), identification of Critical Quality Attributes (CQA), description of the manufacturing process, identification of criticality of Process Parameters (CPP), setting up effective controls, and finally validating the Control Strategy against its initial targets. The described risk management system can be used as basis to design experimental studies and can serve as a knowledge management system that systematically captures product and process information.

QbD as basis for effective development of biopharmaceuticals

249th National Meeting (2015)

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