2 – Analytical tools used in the formulation and assessment of stability of monoclonal antibodies (mAbs)

The analytical and potency assays used to screen formulations and assess stability under storage conditions are discussed. Many of the traditional high-throughput chromatographic, electrophoretic, and spectrophotometric methods are discussed. Some of the latest developed techniques germane to development of the final drug product, including a section on particulate analysis, are included.

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