Concepedia

Comparability assessments of process and product changes made during development of two different monoclonal antibodies

A. S. Lubiniecki, David B. Volkin, M. Marcia Federici, Michael D. Bond, Michael L. Nedved, L C Hendricks, Promod Mehndiratta, Mark W. Bruner, Sudhir Burman, Paul Dalmonte,

Biologicals · 2010 · 85 citations · 9 references

DOI

Concepts

References

9

Characterizing biological products and assessing comparability following manufacturing changes

Arthur J. Chirino, Anthony R. Mire‐Sluis · Nature Biotechnology · 2004 · 364 citations

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Silicone Oil- and Agitation-Induced Aggregation of a Monoclonal Antibody in Aqueous Solution

Renuka Thirumangalathu, Sampathkumar Krishnan, Margaret Speed Ricci et al. · Journal of Pharmaceutical Sciences · 2009 · 289 citations · Full text

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Deamidation of human proteins

Noah E. Robinson, Arthur B. Robinson · Proceedings of the National Academy of Sciences · 2001 · 286 citations · Full text

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Silicone Oil Induced Aggregation of Proteins

LaToya S. Jones, Allyn M. Kaufmann, C. Russell Middaugh · Journal of Pharmaceutical Sciences · 2005 · 279 citations

, , +11

Characterization of the photodegradation of a human IgG1 monoclonal antibody formulated as a high-concentration liquid dosage form

Pei Qi, David B. Volkin, Hui Zhao et al. · Journal of Pharmaceutical Sciences · 2008 · 146 citations · Full text

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