{"product_id":"process-validation-in-manufacturing-of-biopharmaceuticals-hardback","title":"Process Validation in Manufacturing of Biopharmaceuticals - Hardback","description":"\u003cp\u003eThe fourth edition of \u003cem\u003eProcess Validation in Manufacturing of Biopharmaceuticals\u003c\/em\u003e is a practical and comprehensive resource illustrating the different approaches for successful validation of biopharmaceutical processes. A pivotal text in its field, this new edition provides guidelines and current practices, contains industrial case studies, and is expanded to include in-depth analysis of the new Process Validation (PV) guidance from the US FDA.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eKey Features:\u003c\/strong\u003e\u003c\/p\u003e\u003cul\u003e \u003cp\u003e \u003c\/p\u003e \u003cli\u003eOffers readers a thorough understanding of the key concepts that form the basis of a good process validation program for biopharmaceuticals.\u003c\/li\u003e \u003cp\u003e \u003c\/p\u003e \u003cli\u003eIncludes case studies from the various industry leaders that demonstrate application of these concepts.\u003c\/li\u003e \u003cp\u003e \u003c\/p\u003e \u003cli\u003eDiscusses the use of modern tools such as multivariate analysis for facilitating a process validation exercise.\u003c\/li\u003e \u003cp\u003e \u003c\/p\u003e \u003cli\u003eCovers process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration, and practical methods to test raw materials and in-process samples.\u003c\/li\u003e \u003c\/ul\u003e\u003cp\u003eProviding a thorough understanding of the key concepts that form the basis of a good process validation program, this book will help readers ensure that PV is carried out and exceeds expectations. Fully illustrated, this is a much-needed practical guide for biopharmaceutical manufacturers.\u003c\/p\u003e","brand":"Taylor \u0026 Francis","offers":[{"title":"Default Title","offer_id":45584326590702,"sku":"9780367697624","price":268.8,"currency_code":"AUD","in_stock":true}],"url":"https:\/\/bookland.com.au\/products\/process-validation-in-manufacturing-of-biopharmaceuticals-hardback","provider":"Book Land AU","version":"1.0","type":"link"}