Process validation in manufacturing of biopharmaceuticals - Info and Reading Options

"Process validation in manufacturing of biopharmaceuticals" Table Of Contents:

• 1- Guidelines to process validation / Gail Sofer
• 2- Commentary on the US Food and Drug Administration's 2011 : guidance for industry, process validation general principles, and practices / Hal Baseman
• 3- Applications of failure modes and effects analysis to biotechnology manufacturing processes / Robert J. Seely and John Haury
• 4- Process characterization / James E. Seely
• 5- Scale-down models for purification processes : approaches and applications / Ranga Godavarti ... [et al.]
• 6- Adventitious agents : concerns and testing for biopharmaceuticals / Raymond W. Nims ... [et al.]
• 7- Lifespan studies for chromatography and filtration media / Anurag Rathore and Carol Sofer
• 8- Validation of a filtration step / Jennifer Campbell
• 9- Analytical test methods for well-characterized biological and biotechnological products / Nadine Ritter and John McEntire
• 10- Facility design issues : a regulatory perspective / Sue Vargo
• 11- Validation of computerized systems / Monica J. Cahilly
• 12- Process validation with a CMO / Susan Dana Jones, Sheila G. Magil, and Gail Sofer
• 13- Risk management & validation / James Agalloco
• 14- Process validation in membrane chromatography / Suma Ray, Miyako Hirai, and Stefan Fischer-Fruehholz
• 15- Leveraging multivariate analysis tools to qualify scaled-down models / John Pieracci and Helena Yusuf-Makagiansar
• 16- Process validation of a multivalent bacterial vaccine : a novel
• 17- Matrix approach / Narahari S. Pujar ... [et al.]
• 18- Validation of the Zevalin purification process : a case study / Lynn Conley, John McPherson, and Jörg Thömmes
• 19- Viral clearance validation : a case study / Michael Rubino ... [et al.].

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