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In the Quality by Design (QbD) approach to antibody-based therapeutics development, stability characterisation —the probability of a protein unfolding or denaturing— is performed to ensure that structure and function are preserved throughout development and manufacturing.

Antibodies are affected by many factors along their journey to become therapeutics. Stability characterisation assays are therefore pivotal to determine the optimal formulations and storage conditions for each therapeutic.

Read this eBook to learn:

  • Various techniques to measure stability
  • Approaches for monoclonal antibody formulation
  • How stability studies support Investigational New Drug (IND) and Biological License Application (BLA) filings
  • How storage conditions affect mAb stability

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