Detalles del Título
Detalles del Título

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Título Process validation in manufacturing of biopharmaceuticals. - Tercera edición.Libros / Impreso - Libros
Autor(es) Rathore, Anurag Singh, 1973- (Editor)
Sofer, Gail (Editor)
Publicación Boca Raton, Florida : CRC Press/Taylor & Francis Group, ©2012
Descripción Física xvii, 513 páginas : ilustraciones ; 25 cm.
Idioma Inglés;
Series Biotechnology and bioprocessing series (35)
ISBN 1439850933
Clasificación(es) 615.19
Materia(s) Biofarmacia; Biotecnología; Aprobación de medicamentos; Control de calidad;
Nota(s) Incluye referencias bibliográficas e índice.
CONTENIDO: Guidelines to process validation / Gail Sofer -- Commentary on the US Food and Drug Administration's 2011 : guidance for industry, process validation general principles, and practices / Hal Baseman -- Applications of failure modes and effects analysis to biotechnology manufacturing processes / Robert J. Seely and John Haury -- Process characterization / James E. Seely -- Scale-down models for purification processes : approaches and applications / Ranga Godavarti ... [et al.] -- Adventitious agents : concerns and testing for biopharmaceuticals / Raymond W. Nims ... [et al.] -- Lifespan studies for chromatography and filtration media / Anurag Rathore and Carol Sofer -- Validation of a filtration step / Jennifer Campbell -- Analytical test methods for well-characterized biological and biotechnological products / Nadine Ritter and John McEntire -- Facility design issues : a regulatory perspective / Sue Vargo -- Validation of computerized systems / Monica J. Cahilly -- Process validation with a CMO / Susan Dana Jones, Sheila G. Magil, and Gail Sofer -- Risk management & validation / James Agalloco -- Process validation in membrane chromatography / Suma Ray, Miyako Hirai, and Stefan Fischer-Fruehholz -- Leveraging multivariate analysis tools to qualify scaled-down models / John Pieracci and Helena Yusuf-Makagiansar -- Process validation of a multivalent bacterial vaccine : a novel -- Matrix approach / Narahari S. Pujar ... [et al.] -- Validation of the Zevalin purification process : a case study / Lynn Conley, John McPherson, and Jörg Thömmes -- Viral clearance validation : a case study / Michael Rubino ... [et al.].
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CodBarras Localización Piso Signatura Estado Categoría
112741Biblioteca Universidad Icesi2615.19/P963DisponibleCol. General