Your Guide To Efficiently Develop Antibody-Based Therapeutics

The use of monoclonal antibodies (mAb) as therapeutics has been around for over 30 years with the first approval by the FDA in 1986. MAb-based therapeutics are still increasingly popular for the treatment and prevention of many diseases, including cancer and autoimmune disorders, and the efforts to further develop and optimize mAb-based biotherapeutics continue to rise.

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.

Indeed, 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 therefore pivotal to help researchers develop and determine the most appropriate formulations and storage conditions for each individual therapeutic.

In this eBook, we 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 to learn more about biotherapeutic characterization or tasked with performing storage and formulation studies.