Concepedia

Development and Characterization of a Cell Culture Manufacturing Process Using Quality by Design (QbD) Principles

Daniel M. Marasco, Jinxin Gao, Kristi L. Griffiths, Christopher Froggatt, Tongtong Wang, Gan Wei

Advances in biochemical engineering, biotechnology · 2013 · 12 citations · 5 references

DOI

Concepts

References

5

Quality by design for biopharmaceuticals

Anurag S. Rathore, Helen Winkle · Nature Biotechnology · 2009 · 796 citations

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Quality by Design in Biopharmaceuticals

Harry Yang · 2016 · 545 citations

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A Systematic Approach for Scale-Down Model Development and Characterization of Commercial Cell Culture Processes

Feng Li, Y. Hashimura, Ronald Pendleton et al. · Biotechnology Progress · 2006 · 111 citations

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Application of the quality by design approach to the drug substance manufacturing process of an Fc fusion protein: Towards a global multi‐step design space

Alex Eon‐Duval, Pascal Valax, Thomas Solacroup et al. · Journal of Pharmaceutical Sciences · 2012 · 42 citations

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The Use of Routine Process Capability for the Determination of Process Parameter Criticality in Small-molecule API Synthesis

Kevin D. Seibert, Shanthi Sethuraman, Jerry D. Mitchell et al. · Journal of Pharmaceutical Innovation · 2008 · 24 citations

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