“It’s not like making aspirin or a small molecule; this is very complex,” said Norman W. Baylor, a former FDA vaccine expert and president of Biologics Consulting. “That whole process of getting the cells to do what they need to do, making sure the expression is proper, all these steps — there are hundreds and thousands of steps involved in making a vaccine, especially with the new technologies, and each of these steps have to be validated.”

Source: Washington Post May 10, 2021 12:01 UTC