Circumventing Polysorbate Induced Unwanted Immunogenicity and Anaphylaxis

Abstract

The rapidly growing and increasingly effective use of Monoclonal Antibodies (mAbs) and other biotherapeutics in the treatment of neoplastic, autoimmune, and inflammatory diseases is an exciting development. Biotherapeutic formulations are significantly more complicated than small molecule drug formulations, contributing to high development and manufacturing costs. Because biotherapeutic proteins are large, structurally complicated, and somewhat fragile molecules (i.e., compared to small molecule drugs) they often require the inclusion of functional excipients in order to ameliorate undesirable properties such as aggregation or short shelf life, or allow for increased concentration permitting smaller administration volumes and reduced administration times. Biotherapeutic proteins can also be affected by differences in the manufacturing process and efficacy can be affected by differences in formulations.