FDA utilizes a risk assessment stra...

FDA utilizes a risk assessment strategy to evaluate the potential immunogenicity of novel protein therapeutics and licensed results following manufacturing changes. The first sum of two units parts of this article discussed FDA's assessment of the critical factors influencing the immunogenicity of like products and the consequences of immune answers to treated patients. The first part focused forward the clinical consequences of immune answers to protein therapeutics, while the secondary part examined product- and patient-related factors that influence immunogenicity. This third and final part