Biological Products in Medicine Publisher



Daniali M^{1, 2, 3} ; Mousavi T^{1, 2, 3} ; Abdollahi M^{1, 2, 3}
Source: Encyclopedia of Toxicology# Fourth Edition: Volume 1-9 Published:2023

Abstract

Biotherapeutics, possessing 32.3% of all pharmaceutical sales in the United States, have attracted tremendous attention in human diagnostic, preventive, and treatment applications. Vaccines, blood products, hormone extracts, gene/cell-based therapies, tissue-engineered products, and monoclonal antibodies are considered cutting-edge in the management of cancer, autoimmune and immune-based diseases, transplantation, heredity disorders, and, more recently, Coronavirus disease of 2019 (COVID-19). Their large size, complexity, parenteral administration, dysregulation of the immune system balance, toxicity issues from different aspects of carcinogenicity, genotoxicity, reproductive toxicity, ecotoxicity, and clinical safety are key issues that must be taken into account. This chapter focuses on the preclinical and clinical toxicity aspects of different groups of biologics. © 2024 Elsevier Inc. All rights reserved.