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  • Title: Defining process design space for a hydrophobic interaction chromatography (HIC) purification step: application of quality by design (QbD) principles.
    Author: Jiang C, Flansburg L, Ghose S, Jorjorian P, Shukla AA.
    Journal: Biotechnol Bioeng; 2010 Dec 15; 107(6):985-97. PubMed ID: 20683852.
    Abstract:
    The concept of design space has been taking root under the quality by design paradigm as a foundation of in-process control strategies for biopharmaceutical manufacturing processes. This paper outlines the development of a design space for a hydrophobic interaction chromatography (HIC) process step. The design space included the impact of raw material lot-to-lot variability and variations in the feed stream from cell culture. A failure modes and effects analysis was employed as the basis for the process characterization exercise. During mapping of the process design space, the multi-dimensional combination of operational variables were studied to quantify the impact on process performance in terms of yield and product quality. Variability in resin hydrophobicity was found to have a significant influence on step yield and high-molecular weight aggregate clearance through the HIC step. A robust operating window was identified for this process step that enabled a higher step yield while ensuring acceptable product quality.
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