The use of a monoclonal antibody (mAb) as a therapeutic has been around for over 30 years with the first approval by the FDA in 1986. The efforts to further develop and optimize better mAb-based biotherapeutics continue to rise. MAb-based therapeutics are becoming increasingly popular for the treatment and prevention of many diseases, including cancer and autoimmune disorders. In the “Quality by Design” approach for mAb-based therapeutics development, stability characterization—the probability of a protein unfolding or denaturing—is performed to ensure that structure and function are preserved throughout development and manufacturing. Antibodies can be adversely affected by extreme heat, cold, light, reagent concentrations, and many other factors during their journey to become a therapeutic. Stability characterization assays are pivotal, therefore, to help researchers to develop and determine the most appropriate formulations and storage conditions for each individual therapeutic.
In this eBook, we will present various techniques used to measure the stability of biotherapeutics, address the ins-and-outs of monoclonal antibody formulation, present a typical timeline for Investigational New Drug (IND) and New Drug Application (NDA) filing, and delve into how storage conditions affect mAb stability. Continue reading this eBook if you are interested in learning more about biotherapeutic characterization or tasked with performing storage and formulation studies.
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