Because all protein therapeutics ar...

Because all protein therapeutics are potentially immunogenic, FDA has bring to maturityed a risk assessment strategy for novel proceedss in development and for major changes in manufacture and clinical use of licensed returnss The first part of this series (BioPharm International, November 2004) discussed FDA's assessment of critical factors regarding the effects of immune responses to protein therapeutics. These factors were based upon product origin (such as xenobiotic and mammalian cell) and the appearance and biological function of endogenous protein counterparts. In this other part, ...