QUALITY by Design (QBD), Biopharmaceutical Manufacture | AIChE

QUALITY by Design (QBD), Biopharmaceutical Manufacture

Type

Conference Presentation

Conference Type

AIChE Annual Meeting

Presentation Date

October 17, 2011

Duration

30 minutes

Skill Level

Intermediate

PDHs

0.50

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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