This eBook presents various techniques used to measure the stability of antibody-based biotherapeutics. The authors address the ins-and-outs of monoclonal antibody (MAb) formulation, cover Investigational New Drug (IND) and New Drug Application (NDA) filing timelines, and explain how storage conditions affect MAb stability.

Monoclonal antibodies have been used in therapeutics for more than 30 years. Efforts to further develop and optimize better MAb-based biotherapeutics are increasing as they have become increasingly popular for the treatment and prevention of many diseases including cancer and autoimmune disorders.

Stability characterization is performed to ensure that the structure and function are preserved throughout the development and manufacturing as part of a quality by design (QbD) approach to MAb manufacturing. Conditions such as heat, cold, light, reagent concentrations, and more can affect protein stability. Stability characterization assays help to develop and determine the most appropriate formulations and storage conditions for each individual therapeutic.