ABSTRACT
Throughout the history of biologics administered for human use, one can find numerous examples of products that have been contaminated with potential human pathogens. The regulation of biologics was first established by the U.S. federal government in 1902 ( 1) following a serious diphtheria epidemic during which 10 children died after being treated with antitoxin contaminated with tetanus produced from an infected horse. No safety testing had been performed on this product.
