Frontiers in Nanobiomedical Research: Volume 6

Handbook of Immunological Properties of Engineered Nanomaterials

(In 3 Volumes)

Volume 1: Key Considerations for Nanoparticle Characterization Prior to Immunotoxicity Studies

Volume 2: Haematocompatibility of Engineered Nanomaterials

Volume 3: Engineered Nanomaterials and the Immune Cell Function

2^nd Edition

https://doi.org/10.1142/9677 | April 2016

Pages: 1184

Edited by:
Marina A Dobrovolskaia (Leidos Biomedical Research Inc., USA) and
Scott E McNeil (Leidos Biomedical Research Inc., USA)

Handbook of Immunological Properties of Engineered Nanomaterials : Volume 1: Key Considerations for Nanoparticle Characterization Prior to Immunotoxicity Studies

Handbook of Immunological Properties of Engineered Nanomaterials : Volume 2: Haematocompatibility of Engineered Nanomaterials

Handbook of Immunological Properties of Engineered Nanomaterials : Volume 3: Engineered Nanomaterials and the Immune Cell Function

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This unique book provides comprehensive overview of the field of immunology related to engineered nanomaterials used for biomedical applications. It contains literature review, case studies and protocols. The book can serve as a source of information about nanoimmunotoxicology for both junior scientists and experts in the field. The authors have more than 10 years of experience with preclinical characterization of engineered nanomaterials used for medical applications, and they share their experience with the readers. In addition, the international team of experts in the field provides the opinion and share the expertise on individual topics related to nanoparticle physicochemical characterization, hematocompatibility, and effects on the immune cell function . The second edition contains updated chapters from the first edition plus new chapters covering areas of tumor immunology, nanoparticle interaction with lymphatic system, mathematical modeling of protein corona, utilization of nanoparticles for the delivery of antiviral drugs, extensive analysis of nanoparticle anti-inflammatory and immunosuppressive properties, novel ways of protecting therapeutic nanoparticles from the immune recognition, as well as case studies regarding nanoparticle sterilization, complement activation, protein binding and immunotherapy of cancer. The second edition comes in 3 volumes. Volume 1 is focused on nanoparticle characterization, sterility and sterilization, pyrogen contamination and depyrigenation. It also contains overview of regulatory guidelines, protocols for in vitro and in vivo immunotoxicity studies, and correlation between in vitro and in vivo immunoassays. Volume 2 is focused on hematocompatibility of nanomaterials. It provides comprehensive review and protocols for investigating nanoparticle interaction with erythrocytes, platelets, endothelial cells, plasma coagulation factors and plasma proteins forming so called "corona" around nanoparticles. Volume 3 is dedicated to nanoparticle interaction with and effects on the immune cell function. It also contains examples of nanoparticle use for delivery of antiviral and anti-inflammatory drugs.

Contents:

Volume 1: Key Considerations for Nanoparticle Characterization Prior to Immunotoxicity Studies:
- Immunological Properties of Engineered Nanomaterials: An Introduction (Marina A Dobrovolskaia and Scott E McNeil)
- Importance of Physicochemical Characterization Prior to Immunological Studies (Jeffrey D Clogston and Anil K Patri)
- Nanoparticle Sterility and Sterilization of Nanomaterials (Nanda Subbarao)
- Sterilization Case Study 1: Effects of Different Sterilization Techniques on Gold Nanoparticles (Ángela França, Beatriz Pelaz, María Moros, Christian Sánchez-Espinel, Andrea Hernández, Cristina Fernández-López, Valeria Grazú, Jesús M de la Fuente, Isabel Pastoriza-Santos and África González-Fernández)
- Sterilization Case Study 2: Effects of Sterilization Techniques on Silver Nanoparticles (Jiwen Zheng, Jeffrey D Clogston, Anil K Patri, Scott E McNeil and Marina A Dobrovolskaia)
- Surface Adsorbates on Nanomaterials and Their Possible Roles in Host Inflammatory and Toxicological Processing (Clinton F Jones, David G Castner and David W Grainger)
- Endotoxin and Engineered Nanomaterials (Marina A Dobrovolskaia and Scott E McNeil)
- Endotoxin Case Study: Interference of Nanoparticles with the Traditional Limulus Amebocyte Lysate Gel Clot Assay (Melanie Kucki, Christian Cavelius and Annette Kraegeloh)
- Immunotoxicity Testing for Drug–Nanoparticle Conjugates: Regulatory Considerations (Simona Bancos, Katherine M Tyner and James L Weaver)
- In Vitro Assays for Monitoring Nanoparticle Interaction with Components of the Immune System (Marina A Dobrovolskaia and Scott E McNeil)
- Evaluating the Adverse Effects of Nanomaterials on the Immune System with Animal Models (Matthew J Smith, Colleen E McLoughlin, Kimber L White, Jr and Dori R Germolec)
- Understanding the Correlation between in vitro and in vivo Immunotoxicity Tests for Engineered Nanomaterials (Marina A Dobrovolskaia and Scott E McNeil)
Volume 2: Haematocompatibility of Engineered Nanomaterials:
- Nanoparticle Interaction with Plasma Proteins as It Relates to Biodistribution (Lennart Treuel and G Ulrich Nienhaus)
- Protein Binding Case Study 1: Understanding Relationship between Protein Corona and Nanoparticle Toxicity (Marina A Dobrovolskaia, Barry W Neun, Sonny Man, Xiaoying Ye, Matthew Hansen, Anil K Patri, Rachael M Crist and Scott E McNeil)
- Mathematical Modeling of the Protein Corona: Implications for Nanoparticulate Delivery Systems (Daniele Dell'Orco, Martin Lundqvist, Sara Linse and Tommy Cedervall)
- Effects of Nanomaterials on Erythrocytes (Bridget Wildt, Richard A Malinauskas and Ronald P Brown)
- The Effects of Engineered Nanomaterials on Cultured Endothelial Cells (Jan Simak)
- The Effects of Engineered Nanomaterials on the Plasma Coagulation System (Jan Simak)
- The Effects of Engineered Nanomaterials on Platelets (Jan Simak)
- Nanoparticles and the Blood Coagulation System (Anna N Ilinskaya and Marina A Dobrovolskaia)
- Complement Activation (Carolina Salvador-Morales and Robert B Sim)
- Case Study: Complement Activation Related Hypersensitivity Reactions to PEGylated Liposomal Doxorubicin — Experimental and Clinical Evidence, Mechanisms and Approaches to Inhibition (Janos Szebeni, Franco Muggia and Yechezkel Barenholz)
- Lymphatic System: A Prospective Area for Advanced Targeting of Particulate Drug Carriers (Indu Singh, Rajan Swami, Wahid Khan and Ramakrishna Sistla)
Volume 3: Engineered Nanomaterials and the Immune Cell Function:
- Bidirectional Interaction between Nanoparticles and Carrier-Mediated Agents and Cells of the Mononuclear Phagocytic System (Sara K O'Neal, Andrew T Lucas, Whitney P Caron, Gina Song, John C Lay, and William C Zamboni)
- Case Study: Application of LeukoLike Technology to Camouflage Nanoparticles from the Immune Recognition (Naama E Toledano Furman, Roberto Molinaro, Alessandro Parodi, Michael Evangelopoulos, Jonathan O Martinez, Claudia Corbo, Roberto Palomba, Iman K Yazdi and Ennio Tasciotti)
- The Effects of Nanoparticles on Dendritic Cells (Valentyna Fesenkova)
- The Effects of Nanoparticles on Bone Marrow Cells (Ekaterina Dadachova)
- Nanoparticles, Immunomodulation and Vaccine Delivery (Sue D Xiang, Martina Fuchsberger, Tanya De L Karlson, Charles L Hardy, Cordelia Selomulya and Magdalena Plebanski)
- Undesirable Adjuvanticity of Nanoparticles and Its Implication in Modulation of T Helper Responses (Ken-ichiro Inoue)
- Immunosuppressive and Anti-Inflammatory Properties of Engineered Nanomaterials (A N Ilinskaya and M A Dobrovolskaia)
- Nanoparticles as Drug Delivery Vehicels for the Therapy of Inflammatory Disorders (Deepthy Menon, J Gopikrishna, Dhanya Narayanan and Shantikumar V Nair)
- Opportunities and Challenges in Nanotechnology-enabled Antiretroviral Delivery (Neill J Liptrott, Paul Curley, Lee M Tatham and Andrew Owen)
- Nanostructures and Allergy (Silvia Lorenzo-Abalde and África González-Fernández)
- Nanoparticles and Antigenicity (Marina A Dobrovolskaia)
- Local Hyperthermia Treatment of Tumors Induces CD8⁺ T Cell-Mediated Resistance Against Distal and Secondary Tumors (Seiko Toraya-Brown, Mee Rie Sheen, Peisheng Zhang, Lei Chen, Jason R Baird, Eugene Demidenko, Mary Jo Turk, P Jack Hoopes, Jose R Conejo-Garcia and Steven Fiering)

Readership: Researchers, academics, undergraduates and graduates in toxicology, immunotoxicology and nanomedicine, and industry (small and mid biotech companies and big pharmaceutical companies), as well as regulatory agencies (EPA, FDA) and physicians.

"An indispensable handbook for anyone developing nanomedicines or anything that is to be put into or come in contact with the body. Valuable for specialists and a practical guide for non-specialists."

Ai Lin Chun, PhD
Senior Editor, Nature Nanotechnology

"A diverse family of engineered nanomaterials is rapidly gaining attention for use as diagnostics and drug delivery platforms for a variety of disorders, including infectious diseases, cardiovascular disorders, and cancer. However, many of the attractive attributes of nanoparticles are offset by potentially detrimental properties such as the host immune response to these novel materials and their therapeutic payloads. Expanded and updated, the second edition of 'Handbook of Immunological Properties of Engineered Nanomaterials,' edited by Drs. Dobrovolskaia and McNeil, offers a versatile resource for investigators and clinicians working toward the goal of reducing to practice the promising concept of nanomaterials applications in innovative diagnostic and therapeutic strategies. This compilation encompasses state-of-art information on haematocompatibility of engineered nanopreparations, impact of physicochemical features of nanomaterials on their immunological compatibility, best practices in assuring nanomaterials' sterility and lack of endotoxin contamination, biological consequences of nanomaterials' interactions with specific cellular subsets of immune system, capabilities of nanoformulations as adjuvants, vaccines, and drug delivery vehicles, contributed by an impressive constellation of leading experts. It will serve as a cutting edge guide to the design of improved therapeutic nanoformulations with mitigated risks of immunotoxicologic burden."

Stefanie N Vogel, PhD
Professor, University of Maryland, School of Medicine

Dr Dobrovolskaia is a Principal Scientist and a Head of Immunology section at the NCL. Dr Dobrovolskaia directs characterization related to a nanomaterials' interaction with components of the immune system. She monitors acute/adverse effects of nanoparticles as they relate to the immune system, both in vitro and in animal models. Dr Dobrovolskaia is also responsible for the development, validation and performance qualification of in vitro and ex vivo assays to support preclinical characterization of nanoparticles, and for monitoring nanoparticle purity from biological contaminants such as bacteria, yeast, mold and endotoxin. Additionally, she leads structure activity relationship studies aimed at identifying the relationship between nanoparticle physicochemical properties and their interaction with macrophages, components of the blood coagulation cascade, and complement systems.

Prior to joining the NCL, Dr Dobrovolskaia worked as a Research Scientist in a GLP laboratory at PPD Development, Inc. in Richmond, VA. She was responsible for the design, development and validation of bioanalytical ligand-binding assays to support pharmacokinetic and toxicity studies in a variety of drug development projects. She received her M S degree from the Kazan State University in Russia, her PhD from the N N Blokhin Cancer Research Center of the Russian Academy of Medical Sciences in Moscow, Russia, and completed two postdoctoral trainings in immunology at the National Cancer Institute in Frederick, MD and the University of Maryland in Baltimore, MD. Her areas of expertise include cell signaling, innate immunity, immunogenicity and analytical methodology.

Dr McNeil serves as the Director of the Nanotechnology Characterization Laboratory (NCL) for Leidos Biomedical Research and Frederick National Laboratory for Cancer Research, where he coordinates preclinical characterization of nanotech cancer therapeutics and diagnostics. At the NCL, Dr McNeil leads a team of scientists responsible for testing candidate nanotech drugs and diagnostics, evaluating safety and efficacy, and assisting with product development — from discovery-level, through scale-up and into clinical trials. NCL has assisted in characterization and evaluation of more than 300 nanotechnology products, several of which are now in human clinical trials. Dr McNeil is a member of several working groups on nanomedicine, environmental health and safety, and other nanotechnology issues. He is an invited speaker to numerous nanotechnology-related conferences and has several patents pending related to nanotechnology and biotechnology. He is also a Vice President of Leidos Biomedical Research.

Prior to establishing the NCL, he served as a Senior Scientist in the Nanotech Initiatives Division at Leidos where he transitioned basic nanotechnology research to government and commercial markets. He advises industry and State and US Governments on the development of nanotechnology and is a member of several governmental and industrial working groups related to nanotechnology policy, standardization and commercialization. Dr McNeil's professional career includes tenure as an Army Officer, with tours as Chief of Biochemistry at Tripler Army Medical Center, and as a Combat Arms officer during the Gulf War. He received his bachelor's degree in chemistry from Portland State University and his doctorate in cell biology from Oregon Health Sciences University.