Process Validation in Manufacturing of Biopharmaceuticals. (2012)

• Record Type: Book
• Other Names: Rathore, Anurag S
• Contents: Front Cover; Contents; Preface; Editors; Contributors; Chapter 1: Guidelines to Process Validation; Chapter 4: Process Characterization; Chapter 6: Adventitious Agents: Concerns and Testing for Biopharmaceuticals; Chapter 8: Validation of a Filtration Step; Chapter 9: Analytical Test Methods for Well-Characterized Biological and Biotechnological Products; Chapter 10: Facility Design Issues: A Regulatory Perspective; Chapter 11: Validation of Computerized Systems; Chapter 12: Process Validation with a CMO; Chapter 13: Risk Management and Validation. Chapter 14: Process Validation in Membrane ChromatographyChapter 15: Leveraging Multivariate Analysis Tools to Qualify Scaled-Down Models; Chapter 16: Process Validation of a Multivalent Bacterial Vaccine: A Novel Matrix Approach; Chapter 18: Viral Clearance Validation: A Case Study; Back Cover.
• Edition: 3rd ed
• Publisher Details: Hoboken : CRC Press
• Publication Date: 2012
• Extent: 1 online resource (523 pages)
• Subjects: 615.19 615/.19; Biotechnological process monitoring; Pharmaceutical biotechnology -- Quality control; Medicine; Pharmacy; MEDICAL -- Drug Guides; MEDICAL -- Nursing -- Pharmacology; MEDICAL -- Pharmacology; MEDICAL -- Pharmacy; Biotechnological process monitoring; Medicine; Pharmaceutical biotechnology -- Quality control; Pharmacy; Electronic books; Electronic books; Electronic books
• Languages: English
• ISBNs: 9781439850947; 1439850941; 1439850933; 9781439850930
• Notes: Note: Includes bibliographical references.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.