Biotherapeutic formulation factors affecting metal leachables from stainless steel studied by design of experiments

AAPS PharmSciTech

Volumn 13, Issue 1, 2012, Pages 284-294

  Zhou, Shuxia ^a,b   Evans, Brad ^c   Schöneich, Christian ^b   Singh, Satish K ^a  

^a PFIZER INC   (United States)

^b UNIVERSITY OF KANSAS   (United States)

^c Biostatistics   (United States)

Author keywords

Biologics formulation factors; Metal chelator; Metal leachables; Protein drug product drug substance manufacturing; Protein formulation stability

Indexed keywords

ANTIOXIDANT; CHELATING AGENT; CHROMIUM; HISTIDINE; IRON; NICKEL; SILICON; STAINLESS STEEL; SURFACTANT;

ARTICLE; CONCENTRATION (PARAMETERS); CONTROLLED STUDY; DRUG FORMULATION; DRUG STORAGE; LEACHING; MASS SPECTROMETRY; PH; PRIORITY JOURNAL; SHELF LIFE; TEMPERATURE SENSITIVITY;

BIOLOGICAL THERAPY; CHEMISTRY, PHARMACEUTICAL; DRUG CONTAMINATION; DRUG STORAGE; METALS; STAINLESS STEEL;

EID: 84862806934     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-011-9747-2     Document Type: Article

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