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Author:   Alok Kumar Srivastav ,  Priyanka Das
Publisher:   Taylor & Francis Ltd
Imprint:   CRC Press
Weight:   0.740kg
ISBN:  

9781041036357

ISBN 10:   1041036353
Pages:   286
Publication Date:   29 August 2025
Audience:   College/higher education ,  Professional and scholarly ,  Tertiary & Higher Education ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   Not yet available  
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Table of Contents

CHAPTER 1: INTRODUCTION TO BIOMANUFACTURING 1.1 Overview of Modern Biomanufacturing Principles 1.2 Overview of Biomanufacturing 1.3 The Quality by Design Approach 1.4 Technical Considerations in Biomanufacturing 1.5 Phases and Scale-Up in Biomanufacturing 1.6 Lifecycle of Manufacturing 1.7 Integration of Artificial Intelligence in Biomanufacturing CHAPTER 2: RAW MATERIAL AND COMPLIANCE IN BIOMANUFACTURING 2.1 Raw Material Considerations in Biomanufacturing 2.2 Compliance and Quality in Biomanufacturing 2.3 Lean Biomanufacturing 2.4 Artificial Intelligence in Raw Material Management 2.5 Predictive Analytics for Raw Material Quality and Supply Chain Optimization 2.6 Advanced Technologies and Future Directions in Biomanufacturing CHAPTER 3: PROCESS ANALYTICAL TECHNOLOGY (PAT) 3.1 Background and Need for PAT 3.2 Tools for Data Acquisitions 3.3 Software in Fermenters, Flow Filtrations, Chromatography 3.4 Analysis and Design Process Analyzers 3.5 Process Control Tools 3.6 Continuous Improvement and Knowledge Management 3.7 Artificial Intelligence in Process Analytical Technology 3.8 Enhancing data acquisition and process control through machine learning algorithms CHAPTER 4: STANDARD OPERATING PROCEDURES IN BIOTECHNOLOGY 4.1 Upstream Processing of Proteins 4.2 Downstream Processing of Proteins 4.3 Quality Control of Protein Production 4.4 Final Fill and Finish of Product 4.5 Case Studies: Therapeutic Proteins, Monoclonal Antibodies, Human Vaccines 4.6 Artificial Intelligence for Standard Operating Procedures Optimization 4.7 Automating and optimizing SOPs using AI technologies CHAPTER 5: INTRODUCTION TO QUALITY SYSTEMS 5.1 Main Elements of a Quality System 5.2 Essentials of a Quality System 5.3 Practical Implementation of a Quality System 5.4 Structure of a Quality Manual 5.5 Correlation between GMP Requirements (WHO) and ISO 9001:2000 5.6 Artificial Intelligence in Quality Systems 5.7 Leveraging AI to ensure continuous compliance and improvement in quality systems CHAPTER 6: PRINCIPLES AND PRACTICE OF GMP: PERSONNEL AND PREMISES 6.1 Principles of Human Resource Management 6.2 Duties of Senior Management 6.3 Organizational Structures 6.4 Qualification and Profiles Requirement 6.5 Workplace and Job Descriptions 6.6 Health Monitoring and Occupational Health Safety 6.7 Training and Functions Owners Subject to Public Law 6.8 Official Requirements for Premises 6.9 Material & Personnel Flow and Layout 6.10 Air Cleanliness Classes and Grades 6.11 Construction Elements and Barrier Systems 6.12 Artificial Intelligence in Personnel Management and Premises 6.13 AI applications in optimizing HR functions and premises management CHAPTER 7: FACILITIES, EQUIPMENT, AND PHARMACEUTICAL WATER 7.1 Facility Planning and Materials 7.2 Hygienic Design in Solids Handling 7.3 System Controllers and Process Control Systems 7.4 Technical Documentation, Calibration, and Maintenance 7.5 Cleaning of Facilities and Containment in Solids Handling 7.6 Pharmaceutical Water: Qualities, Generation, Distribution, and Storage 7.7 Qualification and Operation of Water Supplies 7.8 Pure Steam Systems 7.9 Artificial Intelligence in Facility Management 7.10 Using AI for predictive maintenance and efficient facility operations CHAPTER 8: QUALIFICATION AND PROCESS VALIDATION 8.1 Official Requirements for Qualification 8.2 Preparation and Documentation of Qualification 8.3 Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) 8.4 Special Cases of Qualification 8.5 Official Requirements for Validation 8.6 Validation Planning and Procedure 8.7 Process Validation and Product Lifecycle 8.8 Cleaning Validation: Master Plan, Scope, Acceptance Criteria, Sampling, Analytical Procedures, Documentation 8.9 Artificial Intelligence in Validation Processes 8.10 Automating qualification and validation processes with AI tools CHAPTER 9: PRODUCTION, SANITATION, AND STERILE PACKAGING 9.1 Sanitation and Personnel Hygiene 9.2 Production Hygiene and Environmental Monitoring 9.3 GMP in the Production Process 9.4 Weigh-In, Identification, and In-Process Control 9.5 Prevention of Cross-Contamination, Reworking, Warehouse, and Logistics 9.6 Sterile Production: Air Lock Concepts, Manufacture of Terminally Sterilized Products, Sterilization Processes 9.7 Aseptic Processing and Freeze-Drying 9.8 Testing for Sterility, Endotoxins, Leakage, and Particles 9.9 Microbiological Monitoring 9.10 Packaging Materials and Processes 9.11 Qualification of a Servo-Controlled Blister Packaging Line 9.12 Blow-Fill-Seal (BFS) Technology 9.13 Artificial Intelligence in Production and Packaging: AI for real-time monitoring and control in production and packaging environments CHAPTER 10: GMP IN REGULATION 10.1 Information on National Bodies and Pharmaceutical Associations 10.2 Overview of Pharmacopeia 10.3 EU Directives and Guidelines 10.4 USA: CFR and FDA Guidelines 10.5 ICH-Guidelines 10.6 PIC/S Guidelines 10.7 GMP of Other Regions 10.8 WHO Guidelines 10.9 Artificial Intelligence in Regulatory Compliance: AI tools for ensuring adherence to regulatory guidelines and proactive compliance .

Reviews

Review: Dr. Babasaheb Ghodke This book stands out as a comprehensive guide that successfully connects artificial intelligence with the complexities of modern biomanufacturing. It provides detailed coverage of process analytical technology, AI-driven controls, and regulatory frameworks that are vital for the biotherapeutics industry. The integration of case studies on proteins, antibodies, and vaccines gives it practical relevance, making it a strong reference for professionals who deal with real-world challenges in production. The emphasis on GMP compliance, facility design, and standards further enhances its utility. A highly applicable, compliance-focused resource that bridges AI innovations with the rigorous demands of biomanufacturing leadership.Review: Dr. Vandita Parashar This work delivers a solid combination of technical insights and regulatory awareness, making it a practical guide for professionals in the field. The structure is logical, moving from the fundamentals of bioprocessing to AI-driven process controls, chromatography, and facility hygiene. The case studies are especially useful in linking theory with practice. While the coverage is strong, further exploration of topics like AI model validation, data integrity, and ethical implications would have made it even more comprehensive. A robust, technically oriented resource that empowers R&D scientists and AI developers with both theoretical insight and practical implementation roadmaps for biopharmaceutical process innovation.Review: Dr. Poonam Jaiswal The book offers an inspiring exploration of how artificial intelligence is reshaping the production of biotherapeutics. It balances foundational explanations with advanced applications, making it approachable yet forward-thinking. Topics such as predictive analytics, data acquisition, automation of workflows, and supply chain management are presented in a way that motivates readers to explore new possibilities. The inclusion of regulatory considerations ensures that the content remains practical, while the discussions on sterile packaging and process validation add depth. An enlightening and user-friendly guide for students and early-career professionals eager to grasp AI’s role in the future of biotherapeutic production.

Author Information

Dr. Alok Kumar Srivastav is an accomplished Assistant Professor in the Department of Health Science at the University of the People, Pasadena, California, USA. His academic background includes a Ph.D., M.Tech, and M.Sc. in Bio-Technology, a Post-Doctoral Fellowship (Research) in Bio-Technology from Lincoln University College, Malaysia, and an MBA in Human Resource Management. He is a distinguished figure in Academia and Research, honored with the “International Pride of Educationist Award” at AIT, Thailand, in 2022 for pioneering contributions to advancing education in the digital era, and recipient of a prestigious “Innovative Academic Researcher Award” at HULT, France, UK, in 2024 for his exceptional creativity, innovation, and impact in academic research. Dr. Priyanka Das serves as an Assistant Professor in the Department of Health Science at the University of the People in Pasadena, California, USA. She holds a Ph.D., M.Tech, and M.Sc. in Biotechnology along with an MBA in Human Resource Management. Prior to her current position, she was a Post-Doctoral Fellowship (Research) in Biotechnology at Lincoln University College, Malaysia. Dr. Priyanka Das is a dedicated scholar, contributing significantly to the field of Biotechnology.

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