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The Role of HX-MS in Biopharmaceutical Comparability Studies

Dingermann, T. (2008) Recombinant therapeutic proteins Production platforms and challenges. Biotechnol J, 3 (1), 90-97. [Pg.244]

Chirino, A.J., Mrre-Sluis, A. (2004) Characterizing biological products and assessing comparability following manufacturing changes. Nat Biotechnol, 22 (11), 1383-1391. [Pg.244]

Lubiniecld, A., VoUdn, D.B., Federici, M., et al. (2010) Comparability assessments of process and product changes made dining development of two different monoclonal antibodies. Biologicals, 39 (1), 9-22. Doblhoflf-Dier, O., BUem, R. (1999) Quality control and assurance from the development to the production of biopharmaceuticals. Trends Biotechnol, 17 (7), 266-270. [Pg.244]

Schiestl, M., Stangler, T., ToreUa, C., et al. (2011) Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol, 29 (4), 310-312. [Pg.244]

Schenerman, M.A., Hope, J.N., Kletke, C., et al. (1999) Comparability testing of a humanized monoclonal antibody (Synagis) to support cell line stability, process validation, and scale-up for manufacturing. Biologicals, 27 (3), 203-215. [Pg.244]


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