CONCLUSION
Quality by Design tools such as design of experiments (DOE) help to provide a more thorough understanding of a product's design
space. Excipient robustness studies using DOE are, thus, used to evaluate and characterize the formulation design space. The
formulation design space is identified by the ranges established during the excipient robustness study to provide an assurance
of quality in the product. Controls included in manufacturing batch records and product specifications ensure that the product
is maintained within the formulation design space so that the quality of the product and safety of the patient are ensured.
At the time of the article's writing, Adeola O. Grillo, PhD, was a senior scientist in the department of drug product sciences, biopharmaceutical development, Human Genome Sciences,
Rockville, MD. She is currently an assistant professor in the department of pharmaceutical sciences at the Feik School of
Pharmacy, University of the Incarnate Word, San Antonio, TX, 210.883.1099, grillo@uiwtx.edu
Martin Kane is an associate director of process statistics in the department of biostatistics, Neçois Penn is a bioprocess associate in the department of drug product sciences, and Melissa Perkins, PhD, is the director of the department of drug product sciences, all in biopharmaceutical development at Human Genome Sciences,
Rockville, MD, melissa_perkins@hgsi.com
.
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