1st Edition
Topical and Transdermal Delivery of Therapeutic Peptides and Proteins Science, Technology, and Clinical Translation
Book Description…………………………………………………………………………….2
Front Matter……………………………………………….…………………………………4
Dedication……………………………………………………………………………………5
Contents…………………………………….……….……………………………………… 6
Preface……………………………………………….………………………………………7
About the Author……………………………………...……………………………………12
Chapter 1. Skin Biology and Drug Delivery 2
Abstract 14
1.0 Introduction 15
1.1 Skin Structure and Function 16
1.1.1 Stratum Corneum Ultrastructure 16
1.1.2 Viable Epidermis and Dermal Layers 19
1.1.3 Skin Immunology and Barrier Function 21
1.1.4 Role of Skin Lipids in the Permeability Barrier 23
1.1.5 Lipid Organization and Structure–Function Relationships 26
1.2 Penetration Pathways Through the Skin 28
1.2.1 Transcellular Route 30
1.2.2 Intercellular Pathway 30
1.2.3 Appendageal Route 31
1.2.4 Factors Affecting Skin Penetration 32
1.2.5 Mathematical Models of Skin Permeation 34
1.3 Challenges in Peptide and Protein Delivery 35
1.3.1 Physicochemical Barriers 36
1.3.2 Enzymatic Degradation 37
1.3.3 Immunological Considerations 41
1.3.4 Stability Challenges 41
1.3.5 Size-Dependent Limitations 43
1.3.6 Bioavailability Issues 48
1.4 Conclusion and Future Perspectives 50
References 50
Chapter 2. Molecular Aspects and Stability Considerations 58
Abstract 58
2.0 Introduction 59
2.1 Structural Characteristics 60
2.1.1 Primary to Quaternary Structure 60
2.1.2 Conformational Stability 64
2.1.3 Structure-Activity Relationships 67
2.1.4 Molecular Size Considerations 70
2.2 Physical Stability 71
2.2.1 Denaturation Mechanisms 72
2.2.2 Aggregation 76
2.2.3 Adsorption Issues 86
2.2.4 Surface Interactions 87
2.3 Chemical Stability 92
2.3.1 Oxidation Pathways 93
2.3.2 Hydrolysis Mechanisms 95
2.3.3 Deamidation Reactions 97
2.3.4 β-Elimination 101
2.3.5 Disulfide Exchange 102
2.3.6 Racemization 103
2.3.7 Multiple Degradation Pathways 103
2.4 Analytical Characterization 106
2.4.1 Spectroscopic Methods 107
2.4.2 Chromatographic Techniques 110
2.4.3 Thermal Analysis 112
2.4.4 Particle Characterization 113
2.4.5 Subvisible Particle Analysis 114
2.4.6 Immunoassays and Bioassays 117
2.5 Conclusions and Future Perspectives 119
2.5.1 Integration of Structural, Stability, and Analytical Principles 119
2.5.2 Key Mechanistic Principles 120
2.5.3 Emerging Analytical Technologies and Future Directions 121
2.5.4 Translational Significance for Therapeutic Development 122
References 123
Chapter 3. Formulation Strategies and Advanced Delivery Systems 151
Abstract 151
3.0 Introduction 152
3.1 Preformulation Considerations 154
3.1.1 Physicochemical Characterization 155
3.1.2 Excipient Compatibility 158
3.1.3 Stability Assessment 160
3.1.4 Analytical Method Development 165
3.1.5 Quality by Design Implementation 169
3.2 Novel Delivery Vehicles 170
3.2.1 Lipid-Based Systems 171
3.2.2 Polymer-Based Systems 179
3.2.3 Advanced Carriers 182
3.3 Stabilization Strategies 186
3.3.1 Buffer Selection 189
3.3.2 pH Optimization 189
3.3.3 Preservative Systems 190
3.3.4 Surfactant Incorporation 191
3.3.5 Metal Complexation 193
3.3.6 Protease Inhibitors 194
3.4 Conclusion 199
References 200
Chapter 4. Physical Enhancement Technologies 225
Abstract 225
4. Introduction 226
4.1 Microporation Technologies 227
4.1.1 Microneedles 227
4.1.2 Other Microporation Methods 243
4.2 Electrical Methods 248
4.2.1 Iontophoresis 248
4.2.2 Electroporation 255
4.3 Energy-Based Methods 260
4.3.1 Sonophoresis / Phonophoresis 260
4.3.2 Magnetophoresis 264
4.3.3 Photomechanical Waves 265
4.3.4 Pressure Wave Systems 266
4.3.5 Microwave-Assisted Delivery 267
4.3.7 Photopneumatic Therapy 268
4.4 Combination Strategies and Technology Selection Framework 269
4.5 Conclusions and Future Perspectives 271
References 274
Chapter 5: Chemical Enhancement Strategies 289
Abstract 289
5.0 Introduction 290
5.1 Penetration Enhancers 293
5.1.1 Classification Systems 293
5.1.2 Principles and Mechanisms 298
5.1.3 Structure-Activity Relationships 299
5.1.4 Safety Considerations 301
5.1.5 Optimization Strategies 302
5.2 Peptide-Mediated Delivery 304
5.2.1 Cell-Penetrating Peptides 304
5.2.2 Skin-Penetrating Peptides 307
5.2.3 Antimicrobial Peptides 308
5.2.4 Performance Comparisons 310
5.3 Chemical Modification Methods 313
5.3.1 Prodrug Design 313
5.3.2 Conjugation Strategies 316
5.3.3 Molecular Modification 319
5.3.4 Targeted Delivery Systems 323
5.4 Combination Strategies 325
5.4.1 Enhancer Combinations 325
5.4.2 Physical-Chemical Synergies 327
5.4.3 Novel Combination Strategies 331
5.5 Conclusion 333
References 334
Chapter 6. Novel Therapeutic Applications 361
Abstract 361
6.0 Introduction 362
6.1 Growth Factor Delivery 363
6.1.1 Wound Healing Applications 365
6.1.2 Tissue Regeneration 370
6.1.3 Stability Considerations 373
6.1.4 Delivery Optimization 375
6.2 Protein-Based Therapeutics 380
6.2.1 Monoclonal Antibodies 381
6.2.2 Therapeutic Enzymes 384
6.2.3 Fusion Proteins 385
6.2.4 Vaccine Delivery 388
6.3 Nucleic Acid Delivery 390
6.3.1 siRNA Delivery 391
6.3.2 DNA Delivery 398
6.3.3 mRNA Applications 407
6.3.4 Stability Considerations 409
6.4 Conclusion 413
References 416
Chapter 7. Manufacturing and Quality Considerations 446
Abstract 446
7.0 Introduction 458
7.1 Process Development 460
7.1.1 Critical Process Parameters 460
7.1.2 Scale-up Challenges 467
7.1.3 Process Validation 470
7.1.4 Quality Control Strategies 473
7.1.5 Continuous Manufacturing 474
7.1.6 PAT Implementation 476
7.2 Quality Management 477
7.2.1 GMP Requirements 477
7.2.2 Documentation Systems 480
7.2.3 Analytical Controls 482
7.2.4 Stability Programs 488
7.3 Packaging Considerations 492
7.3.1 Primary Packaging Selection 492
7.3.2 Material Compatibility 498
7.3.3 Stability Requirements 501
7.3.4 User Considerations 503
7.3.5 Environmental Aspects 505
7.4 Conclusion 507
References 509
Chapter 8: Clinical Development and Safety Assessment 517
Abstract 517
8.0 Introduction 518
8.1 Preclinical Studies 520
8.1.1 Safety Assessment 520
8.1.2 Local Tolerance 525
8.1.3 Systemic Exposure 531
8.1.4 Immunogenicity Evaluation 534
8.2 Clinical Trial Design 542
8.2.1 Patient Population Selection 542
8.2.2 Endpoint Determination 544
8.2.3 Protocol Development 547
8.2.4 Special Populations 551
8.2.4.1 Pediatric Considerations 551
8.2.4.2 Geriatric Applications 555
8.2.4.3 Skin Conditions 557
8.2.4.4 Genetic Variations 559
8.3 Safety Considerations 561
8.3.1 Local Effects 562
8.3.2 Systemic Safety 565
8.3.3 Long-Term Outcomes 569
8.3.4 Post-Market Surveillance 573
Conclusion 583
References 586
Chapter 9. Regulatory Framework and Requirements 619
Abstract 619
9.0 Introduction 620
9.1 Global Regulations 621
9.1.1 FDA Requirements 621
9.1.2 EMA Guidelines 624
9.1.3 ICH Guidelines 626
9.1.4 Regional Variations 629
9.2 Documentation Requirements 631
9.2.1 Common Technical Document 631
9.2.2 Quality Documentation 635
9.2.3 Clinical Documentation 645
9.2.4 Safety Documentation 651
9.3 Post-Approval Requirements 655
9.3.1 Change Management 655
9.3.2 Life Cycle Considerations 665
9.3.3 Safety Reporting 668
9.3.4 Quality Management 676
9.4 Conclusion and Future Perspectives 682
References 684
Chapter 10. Commercial Aspects and Future Perspectives 701
Abstract 701
10.0 Introduction 702
10.1 Market Landscape and Commercial Analysis 704
10.1.1 Global Market Size and Growth Projections 704
10.1.2 Segmentation by Therapeutic Area, Technology Platform, and Geography 705
10.1.3 Competitive Landscape and Key Industry Players 707
10.1.4 Unmet Clinical and Patient Needs 709
10.1.5 Investment Trends, Venture Capital, and Partnership Models 710
10.1.6 Pricing, Reimbursement, and Health Economics 710
10.1.7 Commercial Challenges and Barriers to Adoption 711
10.1.8 Patient-Centric Considerations and Adherence Economics 712
10.2 Case Studies in Translation 713
10.2.1 Successful Commercial Products and Their Development Pathways 713
10.2.2 Discontinued Products and Withdrawn Technologies 715
10.2.3 Analysis of Failure Modes 716
10.2.4 Microneedle Commercialization Case Studies 716
10.2.5 Lessons Learned and Best Practices 719
10.2.6 Comparative Analysis 720
10.3 Artificial Intelligence and Machine Learning Applications 722
10.3.1 Overview of AI/ML Methodologies Relevant to Drug Delivery 722
10.3.2 In Silico Prediction of Skin Permeability and Bioavailability 725
10.3.3 ML-Driven Formulation Optimization 727
10.3.4 AI-Assisted Microneedle Design and Personalization 730
10.3.5 Digital Skin Twins and Personalized Permeation Modeling 732
10.3.6 Deep Learning for Protein Stability and Aggregation Prediction 733
10.3.7 Generative AI for Peptide and Protein Engineering 734
10.3.8 AI in Manufacturing and Process Analytical Technology 738
10.3.9 AI-Enabled Clinical Trial Design and Patient Stratification 741
10.3.10 Regulatory Perspectives on AI/ML in Pharmaceutical Development 742
10.3.11 Data Quality, Model Validation, and Reproducibility Challenges 744
10.3.12 Limitations, Ethical Considerations, and the Human-in-the-Loop Paradigm 745
10.4 Digital Health Integration and Connected Delivery 748
10.4.1 Wearable Biosensors and Continuous Monitoring 748
10.4.2 Closed-Loop and Feedback-Controlled Delivery Systems 751
10.4.3 Smart Patches and Microneedle-Integrated Electronics 753
10.4.4 Internet-of-Medical-Things Ecosystems 758
10.4.5 Mobile Health Applications and Adherence Platforms 759
10.4.6 Real-World Evidence Generation 760
10.4.7 Cybersecurity and Patient Data Privacy 761
10.5 Emerging Technologies and Convergent Platforms 763
10.5.1 Novel Materials 763
10.5.2 Advanced Manufacturing 772
10.5.3 Next-Generation Devices 774
10.5.4 Combination Approaches 775
10.5.5 Precision and Personalized Medicine Integration 776
10.6 Sustainability, Ethics, and Future Research Directions 780
10.6.1 Environmental Sustainability of Delivery Systems 780
10.6.2 Equity, Access, and Global Health Considerations 783
10.6.3 Ethical Dimensions of AI and Personalized Therapy 785
10.6.4 Workforce Development and Interdisciplinary Training Needs 786
10.6.6 Concluding Perspectives and Outlook for the Next Decade 789
Conclusion 792
References 794
Index ……………………………………………………………………………………………828
Biography
Hiep X. Nguyen, Ph.D., DTM, is an internationally recognized pharmaceutical scientist whose decade-long body of work has reshaped how clinicians and researchers think about painless, effective, and patient-administered drug delivery. He currently holds a faculty appointment in the Department of Pharmaceutical and Biomedical Sciences at the College of Pharmacy, California Northstate University, USA and the College of Health Sciences, Nam Can Tho University, Vietnam. In parallel with his academic responsibilities, Dr. Nguyen is the Founder and Chief Executive Officer of Novoremedy® (United States and Vietnam) and the Co-Founder and Chief Executive Officer of CareAllMed LLC (California, USA), and he holds scientific advisory appointments in the United States, Vietnam, and India.
Dr. Nguyen earned his Doctor of Philosophy in Pharmaceutical Sciences from Mercer University, Atlanta, Georgia, and a Degree of Pharmacist from Hanoi University of Pharmacy, Vietnam. He is a US–certified pharmacist through the Foreign Pharmacy Graduate Equivalency Certification (FPGEC) and a Distinguished Toastmaster (DTM) of Toastmasters International. During his graduate training at Mercer University, he was honored with election to the Phi Kappa Phi, Rho Chi, and Sigma Xi honor societies, and he received both the Hewitt T. Matthews Outstanding Graduate Student Award and the Monroe F. Swilley, Jr. Student Research Award.
His scientific contributions cover more than a decade of sustained work in the design, formulation, characterization, manufacturing, and translational development of advanced drug delivery systems, with particular emphasis on microneedle technology, transdermal and topical delivery, injectable therapeutics, and Quality by Design (QbD) product development.
Dr. Nguyen is the author of a seminal single-authored book published by the Taylor & Francis Group, Microneedles: The Future of Drug Delivery (2023), together with five book chapters and more than 30 peer-reviewed articles in prestigious pharmaceutical journals, including the Journal of Controlled Release, European Journal of Pharmaceutics and Biopharmaceutics, Pharmaceutical Research, International Journal of Pharmaceutics, and Molecular Pharmaceutics. He has delivered numerous podium and poster presentations at international, national, and regional conferences, with more than 34 scientific abstracts to his credit.
His broader impact on pharmaceutical product development extends from the laboratory bench to commercial translation. As an industry scientist at American Regent, Inc. and Aurobindo Pharma USA, Inc., he contributed to the development of topical semisolid products, transdermal patches, and multiple injectable pharmaceutical products.
Dr. Nguyen's scholarly recognition reflects the depth of his scientific contributions and his growing international influence. He was named to the 2025 Stanford University list of the world's top 2% most influential scientists and was selected as an Honored Listee in Marquis Who's Who 2026. Additional honors include the American Association of Pharmaceutical Scientists (AAPS) Travelship Award and the 2025 SEED Grant supporting his microneedle research program.
A dedicated educator and mentor, Dr. Nguyen has co-advised two Ph.D. graduates in the United States and currently mentors graduate and professional students across three countries, including pharmacy students in the United States, Vietnam, and India. He has served as Co-Director of the Vietnamese Association of Pharmacists and Pharmaceutical Scientists (VAPPS, USA) since 2014, as Scientific Advisor to the National Institute of Pharmaceutical Technology in Vietnam, as Scientific and Community Service Advisor to the Institute for Drug Delivery and Biomedical Research in India, and as Guest Editor of the journal Pharmaceutics. He serves as a peer reviewer for more than seven international drug delivery journals.
Combining bench science, industrial development, classroom teaching, and entrepreneurship, Dr. Nguyen continues to advance the translation of safe, effective, and patient-friendly therapies from the laboratory toward the patients who need them most.
“There is no paucity of books in the field of transdermals. This one is different because it focuses on peptides and proteins - not present in most of the related volumes. The author of this single volume book is a most serious scientist. His clear prose demonstrates a keen knowledge of many areas of science - including anatomy, chemistry, engineering, and even finance. In addition to peptides and proteins, he covers the knowledge as relates to other molecules. This book will replace many of its predecessors - and will help graduate students, the transdermal industry and regulatory bodies worldwide. We hope that the author will continue his prodigious activity and issue new editions for many years to come.”
Howard Maibach, M.D.
Department of Dermatology
University of California, San Francisco, California, USA
“Dr. Nguyen has written a comprehensive treatise on drug delivery via the skin focused on peptides and proteins. This book covers the full breadth of issues related to skin delivery with a remarkable scientific depth that is extensively referenced. It will be the definitive source of information in the field for years to come.”
Mark R. Prausnitz, Ph.D.
Regents' Professor and Regents’ Entrepreneur
J. Erskine Love Jr. Chair in Chemical & Biomolecular Engineering
Georgia Institute of Technology, Atlanta, Georgia, USA
“Topical and Transdermal Delivery of Therapeutic Peptides and Proteins is a timely and comprehensive reference for scientists working to overcome one of the major challenges in biologic drug delivery. The book connects formulation science, delivery technology, manufacturing, regulatory considerations, and clinical translation in a practical and well-organized manner.”
Aliasger K. Salem, Ph.D.
Lyle and Sharon Bighley Endowed Chair and Professor of Pharmaceutical Sciences
Senior Associate Vice President for Research
University of Iowa, Iowa, USA
“This is a comprehensive and timely text. Therapeutic peptides and proteins have ever-increasing importance in improving therapeutic outcomes for patients. This is the first book that takes such a comprehensive approach to their transdermal and topical delivery, covering the fundamental science in great depth, before focusing on translational development and regulatory considerations. The author is an accomplished scientist and author. This book will be of interest to both undergraduate students and more experienced scientists developing the next generation of topical and transdermal delivery systems for therapeutic peptides and proteins.”
Ryan F. Donnelly, Ph.D.
Chair in Pharmaceutical Technology
Director of Research
School of Pharmacy
Queen's University Belfast, UK
“Given the increasing importance of peptide and protein drugs, this authoritative book is a timely and valuable resource for those within academia and industry. The book comprehensively spans skin structure and function, stability and formulations to manufacturing, regulation and a future view of where topical peptide and protein delivery may take us.”
Adrian Williams, Ph.D., D.Sc.
Professor of Pharmaceutics, Reading School of Pharmacy
University of Reading, UK
“While drug modalities have diversified, administration still relies largely on oral and injectable routes. Topical and Transdermal Delivery of Therapeutic Peptides and Proteins highlights promising future directions for scientists aiming to overcome these constraints, and I highly recommend it.”
Kenji Sugibayashi, Ph.D.
Distinguished Professor, Innovation Base, Josai International University
Distinguished Appointed Professor, Josai University, Sakado, Japan
“Dr. Nguyen’s new book on “Topical and Transdermal Delivery of Therapeutic Peptides and Proteins” fills a unique niche within the pharmaceutical literature. This comprehensive and integrative volume explores an area often overlooked in current textbooks on skin delivery: the delivery of challenging macromolecules such as proteins and peptides. The text begins with the fundamental principles of topical and transdermal delivery, progresses through enabling technologies and translational considerations, and concludes with discussions of international regulatory frameworks and marketing perspectives supported by clinical and commercial case studies. This book serves as an outstanding reference for both industry professionals and graduate students specializing in drug delivery sciences.”
Bozena "Bo" B. Michniak-Kohn, Ph.D., D.Sc. (Hon.), FAAPS, FRSC, M.R.Pharm.S.
Professor of Pharmaceutics, Ernest Mario School of Pharmacy
Director, Center for Dermal Research (CDR) & Laboratory for Drug Delivery (LDD) Life Sciences Building
Rutgers-The State University of New Jersey, New Jersey, USA
“Topical and Transdermal Delivery of Therapeutic Peptides and Proteins is a remarkably comprehensive and timely contribution to the field of drug delivery science. Dr. Nguyen has brought together molecular principles, formulation strategies, enhancement technologies, regulatory considerations, and translational perspectives into a single, authoritative resource that will be valuable to both researchers and industry professionals working in peptide and protein delivery.”
S. Narasimha Murthy, Ph.D.
Chief Scientific Officer, Topical Products Testing LLC, Mississippi, USA
“This book is a timely and comprehensive contribution to the rapidly evolving field of topical and transdermal delivery of therapeutic peptides and proteins. As biologic and peptide-based medicines continue to transform the treatment of diabetes, cancer, autoimmune disease, infection, neurodegeneration, and rare disorders, the need for effective, patient-friendly, non-invasive delivery technologies has become increasingly urgent. This volume provides an authoritative and integrated discussion of skin biology, peptide and protein stability, permeation barriers, advanced formulation systems, physical and chemical enhancement technologies, manufacturing, clinical development, regulatory considerations, and commercialization. Its broad coverage of microneedles, iontophoresis, electroporation, sonophoresis, lipid- and polymer-based systems, nucleic acid delivery, quality-by-design, artificial intelligence and machine learning in formulation optimization, digital skin twins, smart patches, connected delivery systems, and personalized medicine makes it an invaluable reference for pharmaceutical scientists, formulation researchers, regulatory professionals, clinicians, and graduate students. By connecting molecular principles with translational, regulatory, commercial, and emerging digital-health perspectives, this book will serve as an important resource for advancing the next generation of non-invasive peptide and protein therapeutics.”
Mandip Singh Sachdeva, Ph.D.
Professor, Basic Sciences
Pharmaceutics Section Leader
Editor in Chief, Critical Reviews in Therapeutic Drug Carrier Systems
College of Pharmacy and Pharmaceutical Sciences
Florida A&M University, Florida, USA
“Topical and Transdermal Delivery of Therapeutic Peptides and Proteins is a comprehensive and timely reference that addresses one of the most critical challenges in modern drug delivery: the effective delivery of biologics across the skin barrier. By integrating skin biology, peptide and protein stability, advanced formulation strategies, physical and chemical enhancement technologies, manufacturing and quality considerations, regulatory requirements, clinical development, and emerging AI-enabled delivery platforms, this book provides a rare and unified perspective from molecular design to translational implementation. It will serve as an important resource for pharmaceutical scientists, clinicians, industry professionals, and graduate students seeking to advance non-invasive delivery of therapeutic peptides and proteins.”
Hyungil Jung, Ph.D.
Underwood Distinguished Professor, Dept. of Biotechnology
Head of Institute of Advanced Bioindustry Convergence
Founder and CSO, Juvic Inc.
Yonsei University, Seoul, South Korea
“Topical and Transdermal Delivery of Therapeutic Peptides and Proteins is an impressive and remarkably comprehensive work that addresses one of the most important challenges in modern drug delivery. By integrating fundamental skin biology, advanced formulation approaches, physical enhancement technologies, and translational considerations, this book will become a highly valuable resource for researchers, pharmaceutical scientists, and graduate students working in the field of biologics and transdermal delivery.”
Kateřina Vávrová, PharmD, Ph.D.
Vice-Dean for Research and Doctoral Studies
Head of Department of Organic and Bioorganic Chemistry
Head of Skin Barrier Research Group
Charles University, Faculty of Pharmacy, Czech Republic
"This is one of the more comprehensive single-authored treatments of transdermal peptide and protein delivery I have encountered. It would serve as a working reference for scientists in industry and academia alike. It would also be a definitive textbook for graduate programs in drug delivery."
Chien Ngoc Nguyen, Ph.D.
Professor, Hanoi University of Pharmacy
Director, National Institute of Pharmaceutical Technology, Hanoi, Vietnam
“After reviewing the abstract and TOC, I believe this is an important work in the field of topical and transdermal drug delivery. I am particularly impressed by the broader coverage of the topic, from skin philosophy to delivery systems construct and to regulatory aspects of such products. It will be well received by the community.”
Tonglei Li, Ph.D.
Allen Chao Chair and Professor of Industrial and Molecular Pharmaceutics
Purdue University, Indiana, USA
“Over 150 peptide candidates are presently progressing through clinical development globally, with biologic medications increasingly comprising a larger portion of authorized treatments for diabetes, cancer, autoimmune diseases, infections, neurodegeneration, and uncommon genetic disorders. Nonetheless, nearly all sanctioned peptides and proteins are still administered to patients via injection. Topical and Transdermal Delivery of Therapeutic Peptides and Proteins by Dr. Hiep X. Nguyen is the inaugural complete volume dedicated to this scientific challenge. Ten carefully structured chapters elucidate the research from molecular underpinnings to clinical translation throughout more than 800 pages of cohesive text, tables, figures, and references updated through 2026. This constitutes a substantial contribution to the scientific literature, and I endorse this text for graduate students, instructors, and researchers.”
Kevin B. Ita, Ph.D.
Professor, Biological and Pharmaceutical Sciences
College of Pharmacy, Touro University, California, USA
“I am thrilled to share some exciting news about a remarkable new reference book titled "Topical and Transdermal Delivery of Therapeutic Peptides and Proteins," authored by Hiep Nguyen. This book is written in a single, unified voice, making it stand out as an invaluable resource for pharmaceutical scientists, regulatory professionals, quality managers, clinical translational researchers, and graduate students. Whether you are interested in the molecular, technological, regulatory, or clinical aspects of peptide and protein therapeutics delivered via the skin, this publication is an excellent place to start.
Inside, readers will discover a deep and thorough exploration of the science behind non-invasive drug delivery for peptide and protein drugs. The book covers practical manufacturing processes, safety considerations, and dives into the intricacies of clinical trial design and regulatory aspects. Real-world case studies are included to illustrate both the successes and challenges encountered in commercial environments, providing valuable context and insights.
Looking ahead, the book highlights future innovations such as the integration of artificial intelligence in peptide design and the development of smart wearable patches, among other groundbreaking advances. These forward-thinking topics are sure to inspire and open new pathways in research and development. The depth and breadth of this book are truly impressive, and I am confident it will make a valuable and lasting contribution to the scientific community. If you have any interest in these areas, I highly recommend exploring this outstanding resource.”
Imran Ahmed, Ph.D.
R&D Executive Director
American Regent, Inc., New Albany, Ohio, USA
“Dr. Nguyen has written the book in the field of peptide and protein delivery starting from preformulation strategies, novel drug delivery systems approach, challenges to reaching marketed products that has been long needed for all the researchers and academic and industrial world. Across ten chapters, he presents the science from the molecular structure of the stratum corneum through formulations, microneedles and other physical enhancement methods, manufacturing under Quality by Design, regulatory considerations across the FDA, EMA, and ICH frameworks, and the commercial realities revealed by both the successes and the failures of past products. The result is a volume of rare coherence and immediate practical value.”
Çetin Taş, Ph.D.
Professor at Pharmaceutical Technology
Faculty of Pharmacy, Yeditepe University, Istanbul, Turkey
“Congratulations on pulling together a huge and complex field into something clear, coherent, and genuinely useful. I really like how well everything connects. The science, the technologies, the clinical applications, and the regulatory considerations all build logically into a unified, rigorous, and practical reference. This will be of real value to researchers, industry scientists, and advanced students working on peptide and protein delivery through the skin. It feels like a reference people will come back to and should play an important role in shaping how the field moves forward.”
Keng Wooi Ng, Ph.D.
Senior Lecturer in Pharmaceutics
School of Pharmacy
Faculty of Medical Sciences
Newcastle University, UK
“Topical and Transdermal Delivery of Therapeutic Peptides and Proteins tackles a both fascinating and deeply important question: how can we deliver some of today’s most powerful medicines without relying on injections? Right from its opening pages, the book makes clear that this is not just a technical issue, but a scientific and human one - tied to patient comfort, treatment adherence, global access to medicine, and the future of medicine itself. What makes this manuscript especially compelling is the way it brings together complex science with a clear sense of purpose, showing how advances in skin biology, drug formulation, and delivery technologies have the potential to reshape care for many patients. Having had the opportunity to work with Hiep, I have seen firsthand his deep commitment to this field, which is clearly reflected throughout the manuscript. Ambitious, timely, and thoughtfully structured, this book has the potential to become a valuable guide not only for specialists, but for anyone interested in where pharmaceutical innovation is heading next.”
Thomas Kipping, Ph.D.
Associate Director and Head of Enabling Technologies
Merck Life Science KGaA, Darmstadt, Germany
“A masterclass in drug delivery. Topical & Transdermal Peptide and Protein Delivery offers the exact practical insights needed to navigate the complex skin barrier. It is an indispensable blueprint for researchers and drug developers alike.”
Samir Patel, Ph.D.
Chemical Engineer and Entrepreneur
CEO Moonlight Therapeutics
Co-Founder of multiple biotech companies, Georgia, USA
“The authoritative treatise on this timely topic. Exhaustively researched and impeccably organized, Dr. Nguyen's book details the development of the field but also the required next steps to get transdermal delivery into more drug pipelines. Required reading!”
Brian R. Bettencourt, Ph.D.
Owner/Operator, B3 Informatics LLC, Massachusetts, USA
“The effective delivery and bioavailability of peptides, proteins and antibodies is one of the most important challenges facing biopharma product developers today. Both experienced and novice researchers will find this to be a comprehensive and intelligently organized reference book, densely packed with actionable information covering every topic relevant to innovative designers of formulations or devices for large, biomolecule delivery. Because of its extensive bibliographies, multidisciplinary product development teams will find this to be an excellent guide covering current knowledge about skin biology and barrier properties, relevant aspects of peptide and protein chemistry, analytical methods, excipients for formulation design, permeation enhancement strategies, passive and energetic medical device design, quality control, regulatory guidance, and clinical considerations. Topical and Transdermal Delivery of Therapeutic Peptides and Proteins: Science, Technology and Clinical Translation is an essential resource for every biopharmaceutical development library.”
Norman Richardson
Manager Technical Services and New Business Development
BASF Pharma Solutions - North America, New Jersey, USA
