Abstract

A serious clinical event is when an immune response to a therapeutic protein interferes with the biopharmaceutical activity or interacts with an endogenous protein. In recent years, a lot of attention has been paid to the role that protein aggregates and particles in biopharmaceutical formulations play in mediating this immune response. Model frameworks that could reliably and dependably foresee the general immunogenicity of biopharmaceutical protein definitions would be incredibly significant. In an effort to provide this insight, a number of methods, such as in silico algorithms, in vitro tests using human leukocytes, and in vivo animal models, have been developed.