Biomanufacturing
Editat de D. Sathis Kumar, Jagadeesha T., Sandip Kunaren Limba Engleză Hardback – 28 sep 2026
The book provides a comprehensive and forward-looking exploration of the technologies, processes, and innovations that are reshaping the production of biologics and biopharmaceuticals through advanced biomanufacturing.
Biomanufacturing stands at the forefront of a new era in life sciences, reshaping the conception, development, and delivery of advanced biologics and biopharmaceuticals to address global health challenges. Biomanufacturing uses living systems, such as genetically modified cells and microorganisms, to create complex molecules. But these developments also bring about new challenges, such as maintaining strict adherence to Good Manufacturing Practices and ensuring the stability and consistency of biological products. These developments are speeding up production schedules, enhancing product quality, and reducing manufacturing costs. This book offers a comprehensive and forward-looking exploration of the rapidly evolving landscape of biologics production, bringing together contributions from leading experts in biotechnology, engineering, and regulatory science to examine the technologies, strategies, and systems revolutionizing how biologics are developed, scaled, and delivered to patients.
Covering topics such as continuous processing, single-use technologies, process automation, and quality-by-design (QbD), this book serves as both a practical guide and strategic roadmap. It addresses the full biomanufacturing lifecycle-from early-stage development to commercial-scale production-and tackles critical regulatory, scalability, and quality challenges. This essential guide equips you with the insight needed to navigate and lead in this transformative era of pharmaceutical innovation.
Readers will find the volume:
- Explores the latest technologies driving efficiency and innovation in biologics production, including continuous manufacturing and single-use systems;
- Features expert insights from industry leaders, researchers, and regulatory professionals shaping the future of biomanufacturing;
- Covers key regulatory, scalability, and quality challenges with real-world case studies and solutions;
- Bridges academic and industrial perspectives, making it a valuable resource for both newcomers and seasoned professionals.
Audience
This book is designed for professionals and researchers across both academia and industry involved in the development, manufacture and production of biologics and biopharmaceuticals.
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Specificații
Notă biografică
Sandip Kunar, PhD is an Associate Professor in the Department of Mechanical Engineering, Aditya University, Surampalem, Andhra Pradesh, India. He has published more than 60 research papers in various reputed international journals and conference proceedings, 60 book chapters, 20 books, and one patent. His research interests include non-conventional machining processes, micromachining processes, biomanufacturing, advanced manufacturing technology, and industrial engineering.
Jagadeesha T., PhD is an Associate Professor in the Mechanical Engineering Department, the National Institute of Technology Calicut, Kerala, India, with more than 25 years of experience. He has developed workbooks and has four patents and more than 75 publications in international journals and conferences. His research interests are advanced machining, additive manufacturing, fluid power control, advanced materials, and vibration and noise control.
D. Sathis Kumar, PhD is the Principal of Aditya Pharmacy College, Surampalem, Andhra Pradesh, India. He has published 54 research articles in esteemed national and international journals, presented papers at reputed conferences, and authored one book. His primary research areas include analytical method development, statistical optimization using software tools, green analytical chemistry, phytochemical analysis, and quality control studies.
Cuprins
Preface xliii
Acknowledgements xlvii
Part 1: Foundations of Biomanufacturing 1
1 Introduction to Biomanufacturing 3
Sandip Kunar, Jagadeesha T., Anusha Mylavarapu, Ajithkumar Sitharaj, Gurudas Mandal and Satishkumar P.
1.1 Introduction 4
1.2 Transformations in Biomanufacturing 6
1.3 Industrial Biotechnology and Biomanufacturing from a Historical Perspective 9
1.4 Fundamentals of Bioprocessing and Biomanufacturing 11
1.5 Innovations in Bioprocessing 12
1.6 Need to Shift to a Bio-Based Economy 14
1.7 Biological Systems as a Biofactory 15
1.8 Progress in Biomanufacturing 18
1.9 Case Studies of Innovative Bioprocesses 20
1.10 Overview of Biomaterials 22
1.11 Manufacturing Process for Porous Implants 26
1.12 Investment and Strategic Alliances to Boost Commercial Biomanufacturing 28
1.13 Challenges and Limitations in Bioprocessing and Biomanufacturing 33
1.14 Conclusion 35
1.15 Future Prospects in Biomanufacturing 37
2 Mathematical Modeling and Simulation Techniques for Biomanufacturing 47
Jagadeesha T. and Sandip Kunar
2.1 Introduction 48
2.2 Biomanufacturing Processes with Examples 49
2.3 Mathematical Modelling in Biomanufacturing 51
2.4 Simulations in Biomanufacturing 55
2.5 Conclusions and Future Opportunities in Biomanufacturing 63
3 Potential Material for BiöPrinting Applications 67
Amey Dukle, Sirisha Puttabanthi and Mamilla Ravi Sankar
3.1 Introduction 68
3.2 Factors Affecting Bioink Functionality 70
3.3 Natural Polymers for Bioink Preparation 72
3.4 Synthetic Polymer for Bioink Preparation 74
3.5 Composite Materials for Bioink Preparation 76
3.6 Emerging Materials in Bioprinting 77
3.7 Conclusions 80
4 3D Bioprinting in Precision Biomanufacturing: From Design to Functional Tissue Constructs 91
Ajithkumar Sitharaj, Idhayaraja S., Arulmurugan B. and Sandip Kunar
4.1 Introduction 92
4.2 Core Technologies and Mechanisms of 3D Bioprinting 93
4.3 Bioinks: The Core of Functional Bioprinting 97
4.4 Design and Modeling for Bioprinted Constructs 100
4.5 Bioprinting Functional Tissues and Constructs 103
4.6 Translating Bioprinting into Scalable Biomanufacturing 107
4.7 Future Directions and Emerging Trends 107
4.8 Conclusion 108
Part 2: Process Improvement and Lean Integration 113
5 Application of Lean Technologies in Biomanufacturing 115
Ranjita Swain, Rudra Narayan Mohapatro and Sunita Routray
5.1 Introduction to Lean in Biomanufacturing 116
5.2 Principles of Lean Manufacturing 117
5.3 Key Lean Tools and Their Applications in Biomanufacturing 120
5.4 Digital Lean and Smart Biomanufacturing 126
5.5 Challenges and Considerations in Lean Biomanufacturing 127
5.6 Case Studies 132
5.7 Conclusion and Future Perspectives 134
6 Issues and Problems for the Biopharmaceutical Industry 139
Sarthak Prasad Sahoo and Sonali Bhujabal
6.1 Overview of Biopharmaceutical Industry 140
6.2 History and Evolution of the Industry 141
6.3 Scope of the Chapter 142
6.4 Distinction from Traditional Small-Molecule Pharmaceuticals 143
6.5 Impact on Global Health and Economies 144
6.6 Research and Development (R&D) Challenges 146
6.7 Manufacturing and Supply Chain Hurdles 150
6.8 Regulatory and Compliance Burdens 153
6.9 Workforce, Market Access and Commercialization Challenges 154
6.10 Ethical, Societal, and Public Perception Concerns 154
6.11 Future Recommendations or Probable Solutions 156
6.12 Conclusion 156
7 Bio Manufacturing for Sustainable Production 163
Ashok Thulluru, Nawaz Mahammed, Reshma Tadipatri, Sundeep Kadasi, Gouri Sankar Kandukuri and Anusha Sanampudi
7.1 Introduction 164
7.2 Sustainable Bio-Manufacturing (Principles and Frameworks) 166
7.3 Platforms and Technologies in Bio-Manufacturing 169
7.4 Biologics and Biopharmaceuticals: Manufacturing Workflow 172
7.5 Innovations Transforming Bio-Manufacturing 175
7.6 Case Studies in Sustainable Production 178
7.7 Challenges and Regulatory Considerations 179
7.8 Future Directions and Emerging Trends 184
7.9 Conclusion 188
8 Additive Manufacturing for Biomedical Applications: Concepts, Methods, and Future Trends 195
Idhayaraja S., Ajithkumar Sitharaj, Arulmurugan B. and Sandip Kunar
8.1 Introduction 196
8.2 Smart Design Strategies in Biomedical Additive Manufacturing 197
8.3 Bio-Compatible and Functional Material Systems for AM 204
8.4 4D Printing and Stimuli-Responsive Biomaterials in Medicine 208
8.5 Bioprinting and WAAM-Based Scaffold Fabrication for Regenerative Medicine 210
8.6 Conclusion 212
9 Role of Functionally Graded Materials in Biomedical Applications 217
Debarupam Gogoi, Mihir Kumar Pandit and Arun Kumar Pradhan
9.1 Introduction 217
9.2 Fundamentals of Functionally Graded Materials 219
9.3 Biological Rationale for Graded Implants 225
9.4 Classification of Biomedical FGMs 226
9.5 Design Considerations 228
9.6 Manufacturing Techniques in Detail 229
9.7 Orthopedic Applications 231
9.8 Dental Applications 233
9.9 Cardiovascular and Soft-Tissue Devices 236
9.10 Drug-Delivery and Tissue-Engineering Scaffolds 236
9.11 Case Studies and Recent Advances (2024-2025) 237
9.12 Challenges and Future Prospects 238
9.13 Conclusion 241
Part 3: Artificial Intelligence and Digital Transformation 249
10 Advances and Challenges in AI-Driven Sustainable and Green Bio-Manufacturing for Bio-Based Production 251
Sree Sowkhya Thaninki, Pushpalatha Kondamuri, Lakshmi Madhavi Chitra, Parinaya Sri Lotha and Shaik Rafi
10.1 Introduction 252
10.2 Developing Mammalian and Microbial Cell Platforms for Eco-Friendly Bio-Manufacturing 255
10.3 AI Foundation: Tools & Techniques in Bio-Manufacturing 259
10.4 AI-Applications in Bio-Process Development 265
10.5 AI-Enhanced Green Bio-Manufacturing: A Comprehensive Overview 271
10.6 Compliance, Ethics and Governance 274
10.7 Human-in-the-Loop System and SME Engagement 276
10.8 Scalability & Commercial Implementation 279
10.9 Emerging Trends & Future Prospects 281
10.10 Challenges and Recommendations 284
11 Microbial Biomanufacturing Using Agro-Industrial Wastes for Sustainable Production of Biologics and Biopharmaceuticals 295
Lakshmi Madhavi Chitra, K. Sujana, A. Harani, Pushpalatha Kondamuri, Sree Sowkhya Thaninki and Parinaya Sri Lotha
11.1 Introduction 296
11.2 Fundamentals of Microbial Bio-Manufacturing 297
11.3 Agro-Industrial Wastes as Fermentation Substrates 301
11.4 Fermentation Strategies for Waste Valorization 306
11.5 Process Optimization and Lean Bio-Manufacturing 313
11.6 Metabolic Engineering and Synthetic Biology in Bio-Manufacturing 315
11.7 Downstream Processing Biologics 318
11.8 Case Studies 322
11.9 Regulatory Framework and Quality Standards 327
11.10 Future Perspectives and Research Opportunities 329
11.11 Conclusion 333
12 Smart Biomanufacturing: Integrating Lean Technologies and Digital Automation in Biologics Production 343
Thenmozhi Annadurai, Abishek Balasundaram, Bava Dhareni Pandia Rajan and Venkateshan Narayanan
12.1 Introduction 344
12.2 Lean Manufacturing in Biologics Production 346
12.3 Implementation of Lean Tools in Bio-Pharmaceutical Industry 352
12.4 Digital Automation in Smart Biomanufacturing 356
12.5 Integration of Lean with Digitalization in Biomanufacturing 367
12.6 Challenges and Future Perspectives 373
12.7 Conclusion 375
13 Additive Manufacturing for Biomedical Applications 381
Geetika Kumari Salwan and Sayon Dey
13.1 Introduction 381
13.2 Fundamentals of Additive Manufacturing 383
13.3 Materials Use in Biomedical AM 385
13.4 Applications of AM in Biomedical Engineering 386
13.5 Challenges and Limitations 389
13.6 Future Perspectives 389
13.7 Conclusions 390
14 Artificial-Intelligence-Based Lean Biomanufacturing: Analytical Measures to Eliminate Wastes and Maximize Process Efficiency 393
Rompicherla Srividya, K.S.N.V. Prasad, B. Karuna, Bijoy Kumar Purohit, Vijaya Kumar Talari, Appala Naidu Uttaravalli and A.V. Raghavendra Rao
14.1 Introduction to Lean Biomanufacturing and Industry 4.0 394
14.2 AI Technologies Transforming Lean Bioprocesses 399
14.3 AI-Driven Optimization in Upstream and Downstream Operations 404
14.4 Data Integrity, Model Validation, and Regulatory Compliance 409
14.5 Case Studies: AI-Enabled Lean Transformation in Biopharma 414
14.6 Roadmap for Implementing AI-Powered Lean Biomanufacturing 418
14.7 Conclusion 423
Part 4: Emerging Biomaterials and Bio-Printing Innovations 433
15 Emerging Bio-Inks for 3D Bioprinting of Functional Tissues in Biomanufacturing Applications 435
B. Karuna, K.S.N.V. Prasad, Rompicherla Srividya, Navapet Vikas Reddy, Tirumala Shreya, Komere Vasu and A.V. Raghavendra Rao
15.1 Introduction to Bioprinting 436
15.2 Fundamentals of Bio-Inks 443
15.3 Bio-Ink Classification 447
15.4 Important Properties of Bio-Inks 449
15.5 Recent Developments in Bio-Ink Creation 456
15.6 Crosslinking Strategy 462
15.7 Examples of Functional Tissue Fabrication 468
15.8 Industrial and Clinical Translation 475
15.9 Prospects and Research Areas 481
15.10 Conclusions 487
16 Bioprocess Optimization Using Artificial Intelligence and Machine Learning 497
K.S.N.V. Prasad, Bijoy Kumar Purohit, Bhaskar Bethi and A.V. Raghavendra Rao
16.1 Introduction to Bioprocess Optimization 498
16.2 Fundamentals of AI and ML in Bioprocessing 499
16.3 AI/ML Integration in Upstream Bioprocessing 502
16.4 AI/ML in Fermentation Process Control 504
16.5 AI/ML in Downstream Processing and Purification 506
16.6 Common Machine Learning Algorithms in Bioprocess Applications 508
16.7 Data Acquisition and Preprocessing in Biomanufacturing 511
16.8 AI-Driven Process Modeling and Digital Twins 513
16.9 Conclusion 516
17 Biomanufacturing of RNA Based Therapeutics and Vaccines: Advances, Issues and Prospects 521
Rompicherla Srividya, Navapet Vikas Reddy, Tirumala Shreya, Komere Vasu, Appala Naidu Uttaravalli, Manjakuppam Malika and A.V. Raghavendra Rao
17.1 Introduction to RNA-Based Therapeutics and Vaccines 522
17.2 Upstream Processes in RNA Biomanufacturing 524
17.3 Downstream Processes for RNA Purification and Formulation 528
17.4 Technological Innovations in RNA Biomanufacturing 531
17.5 Scalability, GMP Compliance, and Regulatory Considerations 535
17.6 Case Studies from mRNA Vaccine Production 538
17.7 Challenges in RNA Biomanufacturing 541
17.8 Future Prospects and Strategic Pathways 544
17.9 Conclusion 547
Part 5: Bioprocessing and Sustainable Production 551
18 Rapid Biomanufacturing Strategies for Emerging Infectious Diseases: A New Era in Global Health Response 553
K.S.N.V. Prasad, Bhaskar Bethi, Bhanu Radhika, Manjakuppam Malika, B. Karuna, Vijaya Kumar Talari, Appala Naidu Uttaravalli and A.V. Raghavendra Rao
18.1 Introduction to Rapid Biomanufacturing in Global Health 554
18.2 Historical Lessons from Recent Pandemics 559
18.3 Enabling Technologies for Agile Biomanufacturing 564
18.4 Platform Technologies for Biologics Development 568
18.5 Advanced Digital Tools and Process Control 573
18.6 Decentralized and Just-in-Time (JIT) Manufacturing Strategies 578
18.7 Regulatory, Policy, and Supply Chain Frameworks 582
18.8 Future Directions and Roadmap for Resilient Infrastructures 587
18.9 Conclusion 590
19 In-Line Monitoring and Advanced Control Strategies in Downstream Bioprocessing of Biologics 603
V. Sravani Sameera, Kamandla Manasa, K.S.N.V. Prasad, Bhanu Radhika, Karanam Hemanth Kumar, Appala Naidu Uttaravalli and A.V. Raghavendra Rao
19.1 Introduction to Downstream Bioprocessing of Biologics 604
19.2 Principles of In-Line Monitoring in Downstream Processes 608
19.3 Process Analytical Technology (PAT) Tools and Sensors 611
19.4 Advanced Control Strategies in Bioprocessing 615
19.5 Implementation of In-Line Monitoring and Controls 620
19.6 Case Studies and Industry Applications 623
19.7 Challenges and Solutions in Adoption 627
19.8 Future Directions in Intelligent Biomanufacturing 631
19.9 Conclusion 634
20 Design of Experiments for Biopharmaceutical Process Optimization 641
Vijaya Kumar Talari, Baburao Gaddala, Bijoy Kumar Purohit, Stutee Bhoi, A. V. Raghavendra Rao, K.S.N.V. Prasad, Gowrishetty Srinivas and T. Srinivas
20.1 Introduction 642
20.2 Fundamentals of Design of Experiments (DoE) 645
20.3 Quality by Design (QbD) Framework 649
20.4 Key Design of Experiments (DoE) in Biopharma 652
20.5 Applications in Process Development Stages 656
20.6 Case Studies 660
20.7 Challenges and Best Practices 664
20.8 Conclusion 668
21 Zero Waste Biomanufacturing Systems: Concepts and Case Studies 675
Bhaskar Bethi, Vijaya Kumar Talari, Bhanu Radhika Gidla, Bijoy Kumar Purohit, A. V. Raghavendra Rao, Stutee Bhoi and K.S.N.V. Prasad
21.1 Introduction to Zero-Waste Biomanufacturing 676
21.2 Core Concepts of Zero-Waste Biomanufacturing 678
21.3 Technological Approaches 681
21.4 Case Studies 683
21.5 Challenges and Opportunities 693
21.6 Future Directions 696
22 Green Chemistry in Upstream Bioprocessing 707
Vijaya Kumar Talari, Stutee Bhoi and Bijoy Kumar Purohit
22.1 Introduction to Green Chemistry in Upstream Bioprocessing 708
22.2 Sustainable Media Preparation 712
22.3 Green Cell Culture Strategies 716
2.4 Energy-Efficient Fermentation Processes 719
22.5 Metabolic Engineering for Sustainability 722
22.6 Process Intensification for Green Bioprocessing 725
22.7 Case Studies in Green Upstream Bioprocessing 728
22.8 Conclusion 732
23 Regulatory Compliance and Quality¿by-Design (QbD) in Biologic Manufacturing: Ensuring Robust and Scalable Bioproduction 737
Abishek Balasundaram, Bava Dhareni Pandia Rajan, Jenifer Appadurai, Venkateshan Narayanan and Thenmozhi Annadurai
23.1 Introduction 738
23.2 Regulatory Framework for Biologics 739
23.3 Quality-by-Design 748
23.4 QbD Implementation in Biologic Manufacturing 755
23.5 Challenges in the Implementation of QbD 765
23.6 Role of Digital Tools and Automation 767
23.7 Future Direction 770
23.8 Conclusion 771
24 AI-Driven Predictive Maintenance for Biomanufacturing Equipment 777
Anup Ashok, Vijaya Kumar Talari, Bijoy Kumar Purohit, A. V. Raghavendra Rao, Stutee Bhoi and K.S.N.V. Prasad
24.1 Introduction to Predictive Maintenance in Biomanufacturing 778
24.2 Technical Foundations of AI-Driven Predictive Maintenance 780
24.3 Applications of AI in Bioprocessing Equipment 783
24.4 Case Studies: AI-Enabled Predictive Maintenance in Action 785
24.5 Challenges in Implementing AI-Driven Predictive Maintenance 788
24.6 Future Trends in AI-Driven Maintenance for Biomanufacturing 790
24.7 Practical Considerations for Biomanufacturing Leaders 792
24.8 Conclusion 794
Part 6: Quality, Regulation, and Risk Management 801
25 Risk Management and Safety Engineering in Large-Scale Biomanufacturing 803
A.V. Raghavendra Rao, Kolluru Manaswini, Thalluri Lavanya, Mulla Murali Ganesh, Srimukhi Mekala, Chitti Babu Nalluri and Sravani Sameera Vanjarana
25.1 Introduction 804
25.2 Understanding Risk in Biomanufacturing 808
25.3 Safety Engineering Principles 818
25.4 Occupational Safety Management 820
25.5 Environmental Safety and Emission Control 822
25.6 Regulatory Frameworks and Standards 823
25.7 Digital Safety Tools and Automation 825
25.8 Future Directions 827
25.9 Conclusion 828
26 Sustainable Downstream Processing: Green Alternatives for Purification of Biologics 839
A.V. Raghavendra Rao, V. Sravani Sameera, Ch. Vishnu Vardhan, Mohith Patil, Panduga Rahul and Rompicherla Srividya
26.1 Introduction to Sustainable Downstream Processing 840
26.2 Green Chemistry and Engineering Principles in Downstream Processing 844
26.3 Sustainable Cell Harvesting and Clarification Techniques 851
26.4 Green Alternatives in Chromatography and Separation 857
26.5 Integration and Process Intensification Approaches 862
26.6 Life Cycle Assessment (LCA) and Environmental Impact Analysis 867
26.7 Challenges, Industrial Applications, and Future Outlook 872
26.8 Conclusion 875
Part 7: Future Directions and Advances 885
27 Next-Gen Nanocarriers for Transdermal Transport of Therapeutic Biologics 887
Gurugubelli Sowjanya, Varri Ambica Taruni and Kommula L. N. S. S. Dharani Devi
27.1 Introduction 888
27.2 The Skin Barrier and Challenges in Transdermal Delivery 890
27.3 Overview of Nanocarrier Systems 893
27.4 Keen: Stimuli-Responsive Nano Carriers 896
27.5 Sorts of Nanocarriers for Transdermal Delivery 899
27.6 Design of Nanocarriers for Biological Therapeutics 909
27.7 Surface Building and Functionalization 911
27.8 Crossover and Multi-Layered Nanocarriers 913
27.9 Components of Nanocarriers Infiltration through Skin 917
27.10 Preclinical and Clinical Evaluation 921
27.11 Administrative, Fabricating, and Adaptability Aspects 924
27.12 Challenges and Future Directions 928
27.13 Conclusion 929
28 Recent Advances in Biocatalysis and Metabolic Engineering for Biomanufacturing 939
Saivenkatesh Korlam, Sankara Rao Miditana and Satheesh Ampolu
28.1 Introduction 940
28.2 Advances in Biocatalysis 942
28.3 Advances in Metabolic Engineering 945
28.4 Applications in Biomanufacturing 948
28.5 Challenges and Limitations 950
28.6 Future Perspectives 952
28.7 Conclusion 952
References 953
Index 957