Effects of surfaces and leachables on the stability of biopharmaceuticals

Journal of Pharmaceutical Sciences

Volumn 100, Issue 10, 2011, Pages 4158-4170

  Bee, Jared S ^a   Randolph, Theodore W ^b   Carpenter, John F ^c   Bishop, Steven M ^a   Dimitrova, Mariana N ^a  

^a MEDIMMUNE   (United States)

^b UCB 450   (United States)

^c UNIVERSITY OF COLORADO   (United States)

Author keywords

Adsorption; Agitation; Air water interface; Biopharmaceuticals characterization; Formulation; Leachables; Particles; Protein aggregation; Stability; Surface

Indexed keywords

EXCIPIENT; GLASS; GLUE; INTERLEUKIN 2; POLITEF; POLYVINYLCHLORIDE; PROTEIN; RUBBER; SILICONE OIL; STAINLESS STEEL; TUNGSTEN; PROTEIN AGGREGATE; SURFACTANT; WATER;

ADSORPTION; CENTRIFUGATION; CONTAMINATION; DIAFILTRATION; DRUG DELIVERY SYSTEM; DRUG MANUFACTURE; DRUG STORAGE; ENVIRONMENTAL EXPOSURE; ENZYME ACTIVITY; FILTRATION; FREEZE DRYING; FREEZING; HUMAN; INFUSION SYSTEM; MICELLE; PH; PROTEIN AGGREGATION; PROTEIN BLOOD LEVEL; PROTEIN PURIFICATION; PROTEIN STABILITY; PURE RED CELL ANEMIA; QUALITY CONTROL; REVIEW; RISK ASSESSMENT; SYRINGE; THAWING; THROMBOCYTE; VIRUS INACTIVATION; CHEMISTRY; DEVICES; DRUG CONTAMINATION; DRUG PACKAGING; DRUG STABILITY; EQUIPMENT DESIGN; MEDICINAL CHEMISTRY; PHARMACEUTICS; PROCEDURES; SURFACE PROPERTY;

BIOPHARMACEUTICS; CHEMISTRY, PHARMACEUTICAL; DRUG CONTAMINATION; DRUG DELIVERY SYSTEMS; DRUG PACKAGING; DRUG STABILITY; EQUIPMENT DESIGN; PROTEIN AGGREGATES; PROTEIN STABILITY; PROTEINS; SURFACE PROPERTIES; SURFACE-ACTIVE AGENTS; TECHNOLOGY, PHARMACEUTICAL; WATER;

EID: 80052262016     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22597     Document Type: Review

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