IgG1 aggregation and particle formation induced by silicone-water interfaces on siliconized borosilicate glass beads: A model for siliconized primary containers

Journal of Pharmaceutical Sciences

Volumn 102, Issue 3, 2013, Pages 852-865

  Basu, Pinaki ^a   Krishnan, Sampathkumar ^b   Thirumangalathu, Renuka ^c   Randolph, Theodore W ^d   Carpenter, John F ^a  

^a UNIVERSITY OF COLORADO   (United States)

^b Hospira Inc   (United States)

^c AMGEN INC   (United States)

^d UCB 450   (United States)

Author keywords

Particle size; Prefilled syringes; Protein aggregation; Protein formulation; Separation science; Silicone oil; Siliconization; Stability; Subvisible particles; Surfactants

Indexed keywords

GLASS; IMMUNOGLOBULIN G1; POLYSORBATE 20; SILICATE; SILICONE; SILICONE OIL; SODIUM CHLORIDE; SUCROSE; WATER; BORON DERIVATIVE; IMMUNOGLOBULIN G; POLYSORBATE; SILICONE DERIVATIVE;

ARTICLE; CHEMICAL MODIFICATION; CONTAINER; CONTROLLED STUDY; GEL PERMEATION CHROMATOGRAPHY; PARTICULATE MATTER; PH; PROTEIN AGGREGATION; SILICONIZATION; SYRINGE; CHEMICAL MODEL; CHEMISTRY; PARTICLE SIZE; SOLUBILITY; SURFACE PROPERTY;

BORON COMPOUNDS; GLASS; HYDROGEN-ION CONCENTRATION; IMMUNOGLOBULIN G; MODELS, CHEMICAL; PARTICLE SIZE; POLYSORBATES; SILICATES; SILICONE OILS; SILICONES; SODIUM CHLORIDE; SOLUBILITY; SUCROSE; SURFACE PROPERTIES; SYRINGES; WATER;

MLCS; MLOWN;

EID: 84878157047     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23434     Document Type: Article

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