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 Author: 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.