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Publications > Scientific > Quality by Design in the CMO Environment
Quality by Design in the CMO Environment
Published by Admin on 2008/11/10 (1586 reads)
Incorporating quality by design into process development in a contract manufacturing environment can be challenging.  In this case study, design of experiements was used to identify the key and critical operational parameters and their targets for hydrophobic interation chromatogaphy (HIC) used in the purification of an antibody.  Six parameters that typically influence HIC performance were assessed for their effect on elution profile, product yield, and resolution between product and product-related impurities.  Statistical software was used to design experiments and analyze the data.  The data established wide ranges for some parameters and tighter controls were required for others that had a significant effect on product yield.  Some of the parameters also influenced the elution profile and the resolution of product from product-related impurities.  These bench-scale studies established a design space that delivered product with reproducible quality and yields during manufacturing.

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