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Accelerating Formulation for Antibody-Based Therapeutics

In the “Quality by Design” approach to mAb-based therapeutics development, characterizing protein stability helps preserve structure and function.




Monoclonal antibody (mAb)-based therapeutics are increasingly used for treating and preventing many diseases, including cancer and autoimmune disorders. During development and manufacturing, antibodies can be adversely affected by heat, cold, light, reagent concentrations, and many other factors. Stability characterization assays are pivotal to help researchers develop and determine the most appropriate formulations and storage conditions for each individual therapeutic.

Download this ebook from NanoTemper and The Scientist to learn about

  • Techniques used to measure the stability of biotherapeutics
  • The ins-and-outs of monoclonal antibody formulation
  • A typical timeline for Investigational New Drug (IND) and New Drug Application (NDA) filing
  • Storage conditions that may affect mAb stability