Biopharmaceutical proteins characterization

The successful application of CE technology has resulted in dramatic growth of CE as an essential tool for protein characterization, R D, and QC of therapeutic biomolecules. CE methods have clearly been shown to be superior over traditional slab-gel methods. Many biopharmaceutical companies have adopted CE techniques in QC environments for determination of product purity, identity and consistency needed for the release of protein products. The success of validation per ICH guidelines has moved CE technology to a position of greater prominence and ensures the quality release of therapeutic proteins and antibodies. 

Covers characterization and analysis of biopharmaceutical proteins, as these molecules are gaining significance. 

The physicochemical and other properties of any newly identified drug must be extensively characterized prior to its entry into clinical trials. As the vast bulk of biopharmaceuticals are proteins, a summary overview of the approach taken to initial characterization of these biomolecules is presented. A prerequisite to such characterization is initial purification of the protein. Purification to homogeneity usually requires a combination of three or more high-resolution chromatographic steps (Chapter 6). The purification protocol is designed carefully, as it usually forms the basis of subsequent pilot- and process-scale purification systems. The purified product is then subjected to a battery of tests that aim to characterize it fully. Moreover, once these characteristics have been defined, they form the basis of many of the QC identity tests routinely performed on the product during its subsequent commercial manufacture. As these identity tests are discussed in detail in Chapter 7, only an abbreviated overview is presented here, in the form of Figure 4.5. 

A number of different techniques may be used to characterize protein-based biopharmaceutical products, and to detect any protein-based impurities that may be present in that product (Table 7.2). Analysis for non-protein-based contaminant is described in subsequent sections. 

Table 7.2 Methods used to characterize (protein-based) finished product biopharmaceuticals. An overview of most of these methods is presented over the next several sections of this chapter...

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