In the biopharmaceutical industry, consistently manufacturing a safe and high quality protein drug substance can be challenging. Recently, a regulatory structure supporting Quality by Design (QbD) for pharmaceuticals and biopharmaceuticals has been described in International Conference on Harmonization (ICH) Quality documents (Q8 through Q10; available at www.ich.org). Many of the concepts espoused in these ICH documents (e.g. quality target product profile [QTPP], risk-based approaches, product and process understanding, design spaces, control strategies with process analytical technologies [PAT], product life cycle, continuous process verification) are universal for pharma/biopharma manufacturing and can readily be applied to bulk protein production.
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