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.
About this eBook
