Conference Dates
May 8-13, 2016
Abstract
Quality by Design (QbD) has been widely adopted by the pharmaceutical industry as a tool for transforming development, manufacture, and commercialization of drug products. QbD ensures that quality is built into a manufacturing process to consistently produce desired product. As per a FDA guidance1, QbD should be employed at the product development stage to ensure manufacture of a product with predefined quality. Here we present a retrospective QbD approach employed at Shire to define an improved control strategy for a commercial process using risk-based process understanding and characterization. Key challenges and considerations of implementing a QbD strategy on a commercial process are presented with examples of critical quality attribute review, parameter impact assessment, parameter classification review and updated control strategy
Recommended Citation
Anup Agarwal and Eric Hayduk, "Retrospective implementation of quality by design for legacy commercialized enzyme replacement therapies" in "Cell Culture Engineering XV", Robert Kiss, Genentech Sarah Harcum, Clemson University Jeff Chalmers, Ohio State University Eds, ECI Symposium Series, (2016). https://dc.engconfintl.org/cellculture_xv/244