Development and characterization of a cell culture manufacturing process using quality by design (QbD) principles.

The principles of quality by design (QbD) have been applied in cell culture manufacturing process development and characterization in the biotech industry. Here we share our approach and practice in developing and characterizing a cell culture manufacturing process using QbD principles for establishing a process control strategy. Process development and characterization start with critical quality attribute identification, followed by process parameter and incoming raw material risk assessment, design of experiment, and process parameter classification, and conclude with a design space construction. Finally, a rational process control strategy is established and documented.