This article outlines a QbD-based strategy for maintaining comparability of glycosylation during biopharmaceutical scale-up.
It also describes visual informatics tools that aid the implementation of QbD and simplify the analysis of complex information
on drug glycosylation. This strategy is not suitable for all drug developers—it requires a serious consideration of glycosylation
early on in biopharmaceutical development, an adoption of new models for drug realization, and the consequent commitment of
scientific resources. However, the reward should be a therapy that has better clinical performance, is readily scalable, and
that can be brought to market in a timely way.
I thank the following for interesting discussions on QbD, the A-MAb project, and drug glycosylation: Ron Taticek, PhD, Lynne
Krummen, PhD, and Paul Motchnik, PhD, of Genentech, and Michael DeFelippis, PhD, and Bruce Meiklejohn, PhD, of Eli Lilly.
Daryl Fernandes is the chief executive officer of Ludger Ltd., Cuham Science Centre, Oxfordshire, UK, +44 1865 408 554, firstname.lastname@example.org
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