Raj Bawa, MS, PhD, is president of Bawa Biotech LLC, a biotech/pharma consultancy and patent law firm based in Ashburn, Virginia, USA (founded in 2002). He is a registered patent agent licensed to practice before the US Patent Office, scientific advisor to Teva (Israel), visiting research scholar at the Pharmaceutical Research Institute (Rensselaer, NY), and vice president of Guanine, Inc. (Rensselaer, NY). Currently, he is principal investigator of a CDC grant to develop an assay for carbapenemase-resistant bacteria. Dr. Bawa was a primary examiner at the US Patent Office from 1996 to 2002 and an adjunct professor at Rensselaer (Troy, NY) from 1998 to 2018, where he received his PhD (biochemistry/ biophysics). He has authored over 100 publications, co-edited 4 texts, and serves as an associate editor of Nanomedicine (Elsevier).
Janos Szebeni, MD, PhD, DSc, is director of the Nanomedicine Research and Education Center at Semmelweis University School of Medicine in Budapest, Hungary. He is also founder and CEO of SeroScience, Ltd. (based in Boston, Massachusetts), and a full professor of immunology and biology at the University of Miskolc in Hungary. He has made significant contributions to three fields: artificial blood, liposomes, and the complement system. His original works led to the "CARPA" concept, i.e., that complement activation underlies numerous drug-induced (pseudo) allergic (infusion) reactions.
Thomas J. Webster, MS, PhD (H index: 77), is the Art Zafiropoulo Professor and department chair of Chemical Engineering at Northeastern University. He has graduated or supervised over 109 visiting faculty, clinical fellows, post-doctoral students, and thesis completing BS, MS, and PhD students. He is the founding editor-in-chief of the International Journal of Nanomedicine and a past president of the U.S. Society for Biomaterials.
Gerald F. Audette, PhD, has been a faculty member at York University in Toronto, Canada, in the Department of Chemistry since 2006. Currently he is associate professor in the department and a member of the Centre for Research on Biomolecular Interactions at York University. Dr. Audette is the co-editor of volumes 1-4 of the Pan Stanford Series on Nanomedicine and is a subject editor of structural chemistry and crystallography for the journal FACETS.

The enormous advances in the immunologic aspects of biotherapeutics and nanomedicines in the past two decades has necessitated an authoritative and comprehensive reference source that can be relied upon by immunologists, biomedical researchers, clinicians, pharmaceutical companies, regulators, venture capitalists, and policy makers alike. This text provides a thorough understanding of immunology, therapeutic potential, clinical applications, adverse reactions, and approaches to overcoming immunotoxicity of biotherapeutics and nanomedicines. It also tackles critical, yet often overlooked topics such as immune aspects of nano-bio interactions, current FDA regulatory guidances, complement activation-related pseudoallergy (CARPA), advances in nanovaccines, and immunogenicity testing of protein therapeutics.

Current Immune Aspects of Biologics and Nanodrugs: An Overview
Raj Bawa, MS, PhD

Immunological Issues with Medicines of Nano Size: The Price of Dimension Paradox
János Szebeni, MD, PhD, DSc, and Raj Bawa, MS, PhD

Immunotherapy and Vaccines
Johanna Poecheim, PhD, and Gerrit Borchard, PhD

Site-Specific Antibody Conjugation for ADC and Beyond
Qun Zhou, PhD

Current Understanding of Interactions between Nanoparticles and the Immune System
Marina A. Dobrovolskaia, PhD, Michael Shurin, MD, PhD, and Anna A. Shvedova, PhD

Auto-antibodies as Biomarkers for Disease Diagnosis
Angelika Lueking, Heike Göhler, and Peter Schulz-Knappe

The Acceleated Blood Clearance Phenomenon of PEGylated Nanocarriers
Amr S. Abu Lila, PhD, and Tatsuhiro Ishida, PhD

Anti-PEG Immunity Against PEGylated Therapeutics
Amr S. Abu Lila, PhD, and Tatsuhiro Ishida, PhD

Complement Activation: Challenges to Nanomedicine Development
Dennis E. Hourcade, PhD, Christine T. N. Pham, MD, and Gregory M. Lanza, MD, PhD

Intravenous Immunoglobulin at the Borderline of Nanomedicines and Biologicals: Antithrombogenic Effect via Complement Attenuation
Milan Basta, MD, PhD

Lessons Learned from the Porcine CARPA Model: Constant and Variable Responses to Different Nanomedicines and Administration Protocols

Rudolf Urbanics, MD, PhD, Péter Bedocs, MD, PhD, and János Szebeni, MD, PhD
Blood Cell Changes in Complement Activation-Related Pseudoallergy: Intertwining of Cellular and Humoral Interactions
Zsófia Patkó, MD, PhD, and János Szebeni, MD, PhD, DSc

Rodent Models of Complement Activation-Related Pseudoallergy: Inducers, Symptoms, Inhibitors and Reaction Mechanisms
László Dézsi, PhD, László Rosivall, MD, PhD, Péter Hamar, MD, PhD, János Szebeni, MD, PhD, and Gábor Szénási, PhD

Immune Reactions in the Delivery of RNA Interference-Based Therapeutics: Mechanisms and Opportunities
Kaushik Thanki, PhD, Emily Falkenberg, Monique Gangloff, PhD, and Camilla Foged, PhD

Lipid Nanoparticle Induced Immunomodulatory Effects of siRNA
Ranjita Shegokar, PhD, and Prabhat Mishra, PhD

Nanovaccines against Intracellular Pathogens Using Coxiella burnetii as a Model Organism Erin J. van Schaik, PhD, Anthony E. Gregory, PhD, Gerald F. Audette, PhD, and James E. Samuel, PhD

Immunogenicity Assessment for Therapeutic Protein Products

Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products

The "Sentinel": A Conceptual Nanomedical Strategy for the Enhancement of the Human Immune System
Frank J. Boehm and Angelika Domschke, PhD

Immunotherapy for Gliomas and Other Intracranial Malignancies
Mario Ganau, MD, PhD, Gianfranco K. I. Ligarotti, MD, Salvatore Chibbaro, MD, PhD, and Andrea Soddu, PhD

Engineering Nanoparticles to Overcome Barriers to Immunotherapy
Randall Toy, PhD, and Krishnendu Roy, PhD

Metal-Based Nanoparticles and theImmune System: Activation, Inflammation, and Potential Applications
Yueh-Hsia Luo, PhD, Louis W. Chang, PhD, and Pinpin Lin, PhD

Silica Nanoparticles Effects on Hemostasis
Volodymyr Gryshchuk, PhD, Volodymyr Chernyshenko, PhD, Tamara Chernyshenko, Olha Hornytska, PhD, Natalya Galagan, PhD, and Tetyana Platonova, DrSc

Valproate-Induced Rodent Model of Autism Spectrum Disorder: Immunogenic Effects and Role of Microglia
Prabha S. Awale, PhD, James C. K. Lai, PhD, Srinath Pashikanthi, PhD, and Alok Bhushan, PhD

Accelerated Blood Clearance Phenomenon and Complement Activation-Related Pseudoallergy: Two Sides of the Same Coin
Amr S. Abu Lila, Janos Szebeni, and Tatsuhiro Ishida

Current and Rising Concepts in Immunotherapy: Biopharmaceuticals versus Nanomedicines
Matthias Bartneck, PhD

Characterization of the Interaction between Nanomedicines and Biological Components: In vitro Evaluation
Cristina Fornaguera, MSc, PhD

Unwanted Immunogenicity: From Risk Assessment to Risk Management
Cheryl Scott

Emerging Therapeutic Potential of Nanoparticles in Pancreatic Cancer: A Systematic Review of Clinical Trials
Minnie Au, MBBS, Theophilus I. Emeto, PhD, Jacinta Power, MBBS, Venkat N. Vangaveti, PhD, and Hock C. Lai, MBBS

SGT-53: A Novel Nanomedicine Capable of Augmenting Cancer Immunotherapy
Joe B. Harford, PhD, Sang-Soo Kim, PhD, Kathleen F. Pirollo, PhD, Antonina Rait, PhD, and Esther H. Chang, PhD