Concepedia

Compliance and regulatory considerations for the implementation of the multi-attribute-method by mass spectrometry in a quality control laboratory

Annick Gervais, Eef H.C. Dirksen, Thomas Pohl, Karoline Bechtold-Peters, Will Burkitt, Valerio D’Alessio, Simone Greven, Andrew Lennard, Xue Li, Ben Niu,

European Journal of Pharmaceutics and Biopharmaceutics · 2023 · 16 citations · 24 references

DOI

Concepts

References

24

Design of Experiments: Concept and Applications of Plackett Burman Design

K. Vanaja, Reetu Rani · Clinical Research and Regulatory Affairs · 2007 · 252 citations

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Development of a quantitative mass spectrometry multi-attribute method for characterization, quality control testing and disposition of biologics

Richard S. Rogers, Nancy S. Nightlinger, Brittney Livingston et al. · mAbs · 2015 · 222 citations · Full text

, , +16

A View on the Importance of “Multi-Attribute Method” for Measuring Purity of Biopharmaceuticals and Improving Overall Control Strategy

Richard S. Rogers, Michael J. Abernathy, Douglas D. Richardson et al. · The AAPS Journal · 2017 · 147 citations · Full text

, , +17

Multi-Attribute Method for Quality Control of Therapeutic Proteins

Sarah Rogstad, Haoheng Yan, Xiaoshi Wang et al. · Analytical Chemistry · 2019 · 115 citations

, , +16

Effect of Individual Fc Methionine Oxidation on FcRn Binding: Met252 Oxidation Impairs FcRn Binding More Profoundly than Met428 Oxidation

Xuan Gao, Junyan A. Ji, Karthik Veeravalli et al. · Journal of Pharmaceutical Sciences · 2014 · 106 citations · Full text

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