Process validation in manufacturing of biopharmaceuticals : guidelines, current practices, and industrial case studies /: guidelines, current practices, and industrial case studies. (2005)

• Record Type: Book
• Further Information: Note: Edited by Anurag Singh Rathore, Gail Sofer.
• Other Names: Rathore, Anurag S (Anurag Singh), 1973-; Sofer, G. K
• Contents: Cover; Preface; Editors; Contributors; Contents; 1; Guidelines to Process Validation; 1.1 Introduction; 1.2 Current Validation Citations/Problems; 1.3 Validation: Today and Tomorrow; 1.3.1 Today; 1.3.2 Tomorrow; References; 2; Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes; 2.1 Introduction; 2.2 Risk Analysis Methods; 2.3 Two Applications of FMEA; 2.4 FMEA Worksheet; 2.5 Evaluation Criteria: Severity, Occurrence, and Detection; 2.5.1 Severity; 2.5.2 Occurrence; 2.5.3 Detectability; 2.6 Example of FMEA Applied to Process Transfer; 2.7 Next Steps. 3.4.5 Setting Acceptance Criteria for In-Process Performance Parameters: Using Feed Quality as a Process Input3.5 Finishing Up: Reports, Follow-Up, etc.; 3.6 Future Challenges; Acknowledgments; References; 4; Scale-Down Models for Purification Processes: Approaches and Applications; 4.1 Introduction; 4.2 Design of Scale-Down Systems; 4.2.1 Principles; 4.2.2 Evaluation of Scale-Up before Scale-Down; 4.2.3 Scale-Down Model Limitations: Equipment; 4.2.4 Scale-Down Model of an Entire Process Train; 4.3 Examples of Scale-Down Models; 4.3.1 Chromatography. 4.3.1.1 Description of Chromatographic Techniques4.3.1.2 General Scale-Down Principles and Parameters; 4.3.1.3 Primary End Points; 4.3.1.4 Scale-Down Validation of Expanded Bed Chromatography; 4.3.2 Protein Modification Reactions; 4.3.2.1 Hydroxylamine Cleavage Reactions; 4.3.2.2 Enzymatic Cleavage Reactions; 4.3.2.3 PEGylation; 4.3.3 Precipitation; 4.3.3.1 Description of Precipitation Techniques; 4.3.3.2 General Scale-Down Principles and Critical Parameters; 4.3.3.3 Primary End Points; 4.3.4 Microfiltration; 4.3.4.1 Description of Microfiltration Techniques. 4.3.4.2 General Scale-Down Principles and Critical Parameters4.3.4.3 Primary End Points; 4.3.5 Ultrafiltration; 4.3.5.1 Description of Ultrafiltration Techniques; 4.3.5.2 General Scale-Down Principles and Critical Parameters; 4.3.5.3 Primary End Points; 4.3.6 Centrifugation; 4.3.6.1 Description of Centrifugation Techniques; 4.3.6.2 General Scale-Down Principles and Critical Parameters; 4.3.6.3 Primary End Points; 4.3.7 Viral Inactivation; 4.3.7.1 Description of Inactivation Techniques; 4.3.7.2 General Scale-Down Principles and Critical Parameters; 4.3.7.3 Primary End Points.
• Publisher Details: Boca Raton : Taylor & Francis
• Publication Date: 2005
• Extent: 1 online resource (xxi, 578 pages), illustrations
• Subjects: 615/.19; Pharmaceutical biotechnology -- Quality control; Biotechnological process monitoring; Drug approval; Quality control; Biotechnologie pharmaceutique -- Qualité -- Contrôle; Procédés biotechnologiques -- Surveillance; MEDICAL -- Drug Guides; MEDICAL -- Pharmacology; MEDICAL -- Pharmacy; MEDICAL -- Nursing -- Pharmacology; Biotechnological process monitoring; Pharmaceutical biotechnology -- Quality control; Biopharmaceutics; Biotechnology; Technology, Pharmaceutical; Quality Control; Electronic books; Electronic books; Electronic books
• Languages: English
• ISBNs: 0849398584; 9780849398582; 9781574445169; 1574445162
• Related ISBNs: 1574445162
• Notes: Note: Includes bibliographical references and index.; 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.