A simple method for the detection of insoluble aggregates in protein formulations

Journal of Pharmaceutical Sciences

Volumn 96, Issue 7, 2007, Pages 1840-1843

  Li, Bei ^a   Flores, Jose ^a   Corvari, Vincent ^a  

^a ELI LILLY AND COMPANY   (United States)

Author keywords

Antibody; Filtration; Insoluble aggregate; Protein formulation; Staining

Indexed keywords

MONOCLONAL ANTIBODY;

ARTICLE; DRUG FORMULATION; FILTRATION; INTERMETHOD COMPARISON; PARTICULATE MATTER; PROTEIN AGGREGATION; SOLUBILITY; STAINING;

EID: 34547173171     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.20832     Document Type: Article

References (3)

1. Cleland JL, Powell MF, Shire SJ. 1993. The development of stable protein formulations: A close look at protein aggregation, deamidation and oxidation. Crit Rev Ther Drug Carrier Syst 10: 307-377.
2. Koren E, Zuckerman LA, Mire-Sluis AR. 2002. Immune responses to therapeutic proteins in humans - Clinical significance, assessment and prediction. Curr Pharm Biotechnol 3:349-360.
3. Chi EY, Weickmann J, Carpenter JF, Manning MC, Randolph TW. 2005. J Pharm Sci 94:256-274.