NBEs, New biological entities

Development of a stable antibody formulation is often challenging due to conflicting requirements of stability, cost of goods, limitations associated with the route of administration, clinical or administration convenience, and lack of robust models to predict long-term stability. One key difference in formulation development of mAbs and other proteins (referred to as NBEs, new biological entities), compared to traditional small molecules (referred to as NCEs, new chemical entities), is focus on physical stability in addition to chemical integrity of the molecule. Table 26.2 summarizes various degradation pathways for mAbs. 

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