Reactivity Destroys Profitability: Is Class VI Biological Reactivity Testing Enough?

Test protocols for biological reactivity testing are well defined by the U.S. Pharmacopeia; they involve in vitro reactivity testing with mammalian cells and in vivo reactivity testing in animals. Author Dan Klees asserts that many biopharmaceutical companies are not requiring their equipment suppliers to provide evidence of Class VI testing, which could give rise to quality problems during the manufacturing process.