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Process Validation in Manufacturing of Biopharmaceuticals : Biotechnology and Bioprocessing - Anurag Singh Rathore

Process Validation in Manufacturing of Biopharmaceuticals

By: Anurag Singh Rathore (Editor), Scott Rudge (Editor), Hal Baseman (Editor)

Paperback | 20 July 2026 | Edition Number 4

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The fourth edition of Process Validation in Manufacturing of Biopharmaceuticals 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.

Key Features:

  • Offers readers a thorough understanding of the key concepts that form the basis of a good process validation program for biopharmaceuticals.

  • Includes case studies from the various industry leaders that demonstrate application of these concepts.

  • Discusses the use of modern tools such as multivariate analysis for facilitating a process validation exercise.

  • Covers 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.

Providing 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.

You Can Find This Book In

Non-FictionEngineering & TechnologyIndustrial Chemistry & Manufacturing TechnologiesIndustrial ChemistryPharmaceutical TechnologyBiochemical EngineeringBiotechnologyMedicineMedicine in GeneralIndustry & Industrial StudiesManufacturing IndustriesPharmaceutical Industries
ScienceChemistryAnalytical ChemistryTechnology in GeneralEngineering in GeneralBiology, Life SciencesOther Branches of MedicinePharmacologyChemical Engineering

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