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

Reconstitution of lyophilized protein formulations sometimes results in a cloudy solution, depending on the compositions and manufacturing conditions, which causes quality concerns. In this study, the lyophilized protein formulation of recombinant human Interleukin-11 (rhIL-11) was investigated usin...

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Veröffentlicht in:	International journal of pharmaceutics 2007-08, Vol.340 (1), p.34-41
Hauptverfasser:	Hirakura, Yutaka, Yamaguchi, Hideto, Mizuno, Masayasu, Miyanishi, Hideo, Ueda, Satoshi, Kitamura, Satoshi
Format:	Artikel
Sprache:	eng
Schlagworte:	Amorphous Biological and medical sciences Calorimetry, Differential Scanning Chemistry, Pharmaceutical Chromatography, Gas Crystallization Crystallography, X-Ray Freeze Drying General pharmacology Heterogeneity Humans Interleukin-11 - chemistry Lot-to-lot variation Lyophilized formulation Medical sciences Nephelometry and Turbidimetry Pharmaceutical Solutions - chemistry Pharmaceutical Solutions - standards Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments Powder Diffraction Protein Conformation Quality Control Recombinant Proteins - chemistry Solubility Technology, Pharmaceutical - methods Time Factors TSC TSDC Water - chemistry
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