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continues. A systematic and consistent application of
science-based risk assessment during development
and continued improvement of the manufacturing
control strategy remains crucial in ensuring product
quality throughout the product lifecycle.
References
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setting specifications. London, UK. September 9, 2011. https://
www.ema.europa.eu/documents/presentation/presentation-whatcontrol-cqas-cpps-thomas-stangler-behalf-ega_en.pdf
8.
Barnes
CAS The role of the critical quality attribute assessment in
biotherapeutic product development. CASSS Midwest discussion
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com/www.casss.org/resource/resmgr/mwdg/1016_mwdg_
SrebalusBarnes.pdf
9.
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10.
Moussa EM, Panchal JP, Moorthy BS, et al. Immunogenicity of
therapeutic protein aggregates. J Pharm Sci 2016; 105: 417-430.
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of biotherapeutics. J Immunology Res 2016; article ID 5358272
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antibody aggregation. Amer Pharm Rev 2018; March
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chemical modification sites of trastuzumab and endogenous human
immunoglobulins at physiological conditions. Communications
Biology 2018; 1, article number 28
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impurities in large and small molecule pharmaceutical excipients -
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pharmaceuticals: an update. Pharm Res 2010; 27:544-575.
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perspectives for protein-based therapeutics. 2016; Expert Rev.
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using QbD principles. Biologicals 2016: 44: 319-331.
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conference, Lister Hill, MD, September 25-26, 2013.
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Author Biographies
Dr. Christine P. Chan is currently principal scientist in
Global Manufacturing Science & Technology, Industrial
Affairs at Sanofi. She is a protein biochemist with
broad experience in the biopharmaceutical industry,
including prior experience at Sandoz Pharmaceuticals
and Merck & Co., Inc. She specializes in the analysis
of recombinant products produced from mammalian
cells for vaccines and biologics development. Her
application experience includes expression cell line
selection, drug substance and drug product process
development, manufacturing tech transfers and
lifecycle management of commercialized products.
21

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eBook: Analytical Method and QC Testing Strategies for Biologics Production

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