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Immune Aspects of Biopharmaceuticals and Nanomedicines

Immune Aspects of Biopharmaceuticals and Nanomedicines

edited by Raj Bawa, Janos Szebeni, Thomas Webster and Gerald F. Audette

“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

eBook Hardcover

Format: eBook
ISBN: 9780203731536
Series: Jenny Stanford Series on Nanomedicine
Subject: General Biomedical Engineering
Published: November -0001

For Course Instructors: Inspection Copies

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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.

About the Series Editor

Dr. Raj Bawa is president of Bawa Biotech LLC, a biotech/pharma consultancy and patent law firm based in Ashburn, Virginia, that he founded in 2002. He is an entrepreneur, professor, inventor, and registered patent agent licensed to practice before the US Patent Office. Trained as a biochemist and microbiologist, he is currently an adjunct professor at Rensselaer Polytechnic Institute in Troy, New York, and serves as a scientific advisor to Teva Pharmaceutical Industries, Israel. In 2008, he and Dr. Esther Chang of Georgetown Medical Center founded the American Society for Nanomedicine. He has authored over 100 publications and coedited 4 books and serves on the editorial board of 14 peer-reviewed journals.

Key Features:

A stand‐alone, easily accessible volume that examines the provide a broad survey of various topics pertaining to the immune aspects of biopharmaceuticals and nanomedicines, both beneficial and adverse.
An essential reference for the novice and expert alike in diverse areas such as medicine, law, biotechnology, nanotechnology, pharmaceutical sciences, toxicology, drug development, regulatory science and governmental affairs
The comprehensive text highlights both cutting‐edge technological advances and also addresses critical topics such as nano-bio interactions, toxicity and FDA regulatory issues.

Raj Bawa, PhD, MD, is president of Bawa Biotech LLC (founded 2002), a biotech/pharma consultancy and patent law firm based in Ashburn, Virginia. Trained as a microbiologist and biochemist, he is an inventor, author, entrepreneur, professor, and registered patent agent (since 2002) licensed to practice before the US Patent & Trademark Office. He is currently scientific advisor to Teva Pharmaceutical Industries, Israel (since 2010); visiting research scholar at Pharmaceutical Research Institute of Albany Pharmacy, Albany, New York; and full professor (adjunct) at NOVA in Annandale, Virginia (since 2004). He is VP/chief IP officer at Guanine, Inc., in Rensselaer, New York (since 2017), a company focused on rapid, accurate detection of infective pathogens. Dr. Bawa has served as a principal investigator of various NCI research grants, and most recently as a principal investigator of a CDC grant to develop an assay for carbapenemase resistant bacteria. Previously, he was an adjunct professor at Rensselaer Polytechnic Institute, Troy, New York, from 1998 to 2018. He held various positions at the US Patent Office, including primary examiner from 1996 to 2002. He earned a BSc (Honors School) in microbiology, MS in cancer biology, PhD in biophysics/biochemistry, and MD. Currently, he is a life member of Sigma Xi, cochair of the nanotech and precision medicine committees of the American Bar Association and founding director of the American Society for Nanomedicine (established 2008). He has authored over 100 publications, edited 10 texts, and serves on the editorial boards of numerous peer-reviewed journals, including serving 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

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