Process validation in manufacturing of biopharmaceuticals / edited by Anurag Rathore, Gail Sofer.

Incluye referencias bibliográficas e índice.

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.].