Macromolecular therapeutics standards

FIGURE 4.3 The impact of matrix on assay performance. The matrix effect (nonspecificity) could be additive or inhibitory. The open circles represent the standard curve when the macromolecular therapeutic was spiked into a buffer matrix. The solid circles represent an additive effect when the standard curve was prepared in 100% matrix, and the closed triangles represent an example where there was an inhibitory effect when the standards were prepared in 100% matrix. 

Biopharmaceuticals and biologies, often grouped together as macromolecular therapies, or just macromolecules, differ in many ways from small-molecule chugs. The differences between these two general classes of therapeutics are summarized in Table 9.1. It is the very nature of these differences that necessitates different methods of bioanalysis as well as a dedicated look at both types of molecules as reference standards. 

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