Introduction to Vaccine Cell Substrates 2004

摘要

Cell substrates are the cells used in the manufacture of viral vaccines. Essentially all viral vaccines (except synthetic peptide vaccine candidates) are manufactured in some type of cell substrate. Vaccine cell substrates must, thus, be characterized, by the manufacturer, to ensure their suitability for use in the production of their product.Why are cell substrates an issue requiring a three-day conference (and many in the past) ? The risk of a production substrate to the safety and quality of biological products was most famously, and perhaps originally, identified in a case known as "a horse named Jim" - Jim was the name of a horse (an animal substrate - precursors to animal cell culture substrates) used to obtain diphtheria anti-toxin (a serum product). Unfortunately, Jim became infected with tetanus and thus, so was the last lot of diphtheria anti-toxin made from his serum. At least 13 children receiving this anti-toxin died of tetanus as a result of this contamination. This infamous tragedy led to the U.S. Congress approving the Pure Food and Drug Act of 1906, forming the precursor totoday's Food and Drug Administration [1].