Abstract
Quality by Design (QbD) of biopharmaceuticals assumes that desired properties of the final drug product can be predicted with the help of various analytical and characterization methods during the development process. This should be translated into a sound, scientific understanding of drug behavior to design a stability space with clearly defined parameters that produce acceptable product quality attributes. In the QbD framework, the combination and interaction of multiple input variables that have been demonstrated to provide assurance of quality is called the design space. Approaches for identifying the design space in the biopharmaceutical industry generally rely on statistical design of experiments (DOEs) which can be resource intensive (Horvath et al., Mol Biotechnol 45(3):203–206, 2010; Ng and Rajagopalan, Quality by design for biopharmaceuticals: perspectives and case studies, Wiley, Hoboken, 2009). In cases where the number of variables is large, performing a full factorial DOE may be resource intensive. The automated high-throughput methods have been found to be useful in exploration of multiple conditions, defined by so many variables. In this chapter, we describe the use of QbD for applications of automation and high-throughput technology in biopharmaceutical processes from early molecular assessment to the late stages of commercial drug development. High-throughput techniques reinforce the QbD approach not only by providing a large pool of data points using minimal resources but also by obtaining comparable and structural results, which allow thorough statistical analysis.
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Acknowledgments
Authors would like to thank Chris Garvin, William Valentine, Idalisse Gonzales, Jose Vidal, and Gloria Ruiz of Amgen related to providing data and information for real-time multivariate monitoring of fill and finish operations.
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Razinkov, V., Becker, J., Undey, C., Freund, E., Jameel, F. (2015). Automation and High-Throughput Technologies in Biopharmaceutical Drug Product Development with QbD Approaches. In: Jameel, F., Hershenson, S., Khan, M., Martin-Moe, S. (eds) Quality by Design for Biopharmaceutical Drug Product Development. AAPS Advances in the Pharmaceutical Sciences Series, vol 18. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-2316-8_20
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