Your Guide To Efficiently Develop Antibody-Based Therapeutics
In the “Quality by Design” approach for monoclonal antibody (mAb)-based therapeutics development, stability characterization—the probability of a protein unfolding—is performed to ensure that structure and function are preserved throughout development and manufacturing.
Therefore, stability characterization assays are pivotal to develop and determine the best formulations and storage conditions for each therapeutic.
If you are interested in biologics characterization, or tasked with performing storage and formulation studies, read this eBook to learn about:
- Various methods to measure the stability of biotherapeutics
- The ins and outs of monoclonal antibody formulation
- A typical timeline for Investigational New Drug (IND) and Biological License Application (BLA) filings
- Storage conditions and how they affect mAb stability