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Updated: May 10, 2026

Process Optimization using High Throughput Automated Micro-Bioreactors in Chinese Hamster Ovary Cell Cultivation
Published on: May 18, 2020
Development and characterization of a cell culture manufacturing process using quality by design (QbD) principles
Daniel M Marasco1, Jinxin Gao, Kristi Griffiths
1Bioproduct Research and Development, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, 46285, USA, marasco_daniel_m@lilly.com.
Abstract:
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.
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