Immunologic endpoints for guiding biologic drug development

The presence of host cell and drug impurities in biologic drug preparations can have repercussions on drug safety and efficacy by triggering innate immune responses that may amplify adaptive immune responses to a protein therapeutic. Effects of innate immune response modulating impurities (IIRMIs) depend on the a variety of parameters, such as the quantity and type of the impurity as well as the dose and route of drug administration. Challenges in developing methods to quantify and characterize the qualitative nature of an innate immune response to biologic drug preparations will be discussed, as will the implementation of such methods in assessing the potential impact of manufacturing decisio