Detection of lot-to-lot variations in the amorphous microstructure of lyophilized protein formulations

International Journal of Pharmaceutics

Volumn 340, Issue 1-2, 2007, Pages 34-41

  Hirakura, Yutaka ^a   Yamaguchi, Hideto ^a   Mizuno, Masayasu ^a   Miyanishi, Hideo ^a   Ueda, Satoshi ^a   Kitamura, Satoshi ^a  

^a ASTELLAS PHARMA INC   (Japan)

Author keywords

Amorphous; Heterogeneity; Lot to lot variation; Lyophilized formulation; TSC; TSDC

Indexed keywords

RECOMBINANT INTERLEUKIN 11;

ANALYTIC METHOD; ARTICLE; DIFFERENTIAL SCANNING CALORIMETRY; DISSOLUTION; DRUG QUALITY; FREEZE DRYING; INVERSE GAS CHROMATOGRAPHY; PRIORITY JOURNAL; PROTEIN STRUCTURE; QUALITY CONTROL; STRUCTURE ANALYSIS; THERMALLY STIMULATED DEPOLARIZED CURRENT; TURBIDIMETRY; X RAY POWDER DIFFRACTION;

CALORIMETRY, DIFFERENTIAL SCANNING; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, GAS; CRYSTALLIZATION; CRYSTALLOGRAPHY, X-RAY; FREEZE DRYING; HUMANS; INTERLEUKIN-11; NEPHELOMETRY AND TURBIDIMETRY; PHARMACEUTICAL SOLUTIONS; POWDER DIFFRACTION; PROTEIN CONFORMATION; QUALITY CONTROL; RECOMBINANT PROTEINS; SOLUBILITY; TECHNOLOGY, PHARMACEUTICAL; TIME FACTORS; WATER;

EID: 34447268217     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2007.03.016     Document Type: Article

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