1st Edition

Immune Aspects of Biopharmaceuticals and Nanomedicines

    1038 Pages
    by Jenny Stanford Publishing

    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 Bedőcs, 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

    Biography

    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.

    "This outstanding volume represents a review of the various effects of biopharmaceuticals and nanomedicines on the immune system: immunotherapy, vaccines, and drug delivery; challenges and overcoming translational barriers stemming from immunotoxicity; strategies to designing more immunologically friendly formulations."
    —África González-Fernández, PhD, MD, Professor of Immunology and President of the Spanish Society of Immunology, University of Vigo, Spain

    "For those who are specialists, and for those interested in a broader understanding of biologics and nanomedicines, this is a superb book, with internationally accomplished contributors. It serves both as a reference and as a practical guide to the newest advances in these important fields. Highly recommended!"
    —Carl R. Alving, MD, Emeritus Senior Scientist, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA

    "A skillfully produced book that addresses an often-missed topic: immune aspects of biologicals and nanoscale therapeutics, with an emphasis on clinical relevance and applications."
    —Rajiv R. Mohan, PhD, Professor and Ruth M. Kraeuchi Missouri Endowed Chair Professor, University of Missouri, Columbia, USA

    "An indispensable masterpiece! It represents a rich source of information on interactions of biologics and nanodrugs with the immune system—all critical for medical applications. Volume 3, once again, achieves the series’ high standards."
    —László Rosivall, MD, PhD, DSc Med, Med habil., Széchenyi Prize Laureate and Professor, Faculty of Medicine, Semmelweis University, Budapest, Hungary

    "Hats off to Dr. Bawa for producing yet another impressive volume in terms of scope, timeliness, and relevance. With expert contributions from around the globe, this book addresses topics germane to researchers, clinicians, drug and biotherapeutic companies, regulators, policymakers, and patients."
    —Sara Brenner, MD, MPH, Associate Professor and Assistant Vice President, SUNY Polytechnic Institute, Albany, New York, USA

    "Marvelous! This timely book shows clearly that while an immune reaction to "nano-exposure" is usually unwanted, the same response also bears an immense potential."
    —Silke Krol, PhD, IRCCS Istituto Tumori "Giovanni Paolo II" and Fondazione IRCCS Istituto Neurologico "Carlo Besta," Italy

    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.