2 - Analytical tools used in the formulation and assessment of stability of monoclonal antibodies (mAbs)浅析.pdfVIP
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2 - Analytical tools used in the formulation and assessment of stability of monoclonal antibodies (mAbs)浅析
Analytical tools used in the 2
formulation and assessment
of stability of monoclonal
antibodies (mAbs)
Analytical methods for evaluation of monoclonal antibody
stability
As will be discussed in Chapter 3 there are several degradation pathways for proteins and
monoclonal antibodies (mAbs). The mAb DP requires formulations that are sufficient to
meet the specific TPP for the specific mAb. However, in order to do this several analytical
methods are used to determine the stability of the mAb and set a shelf life for the
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