| Popis: |
Appropriate and complete analysis and characterization of biopharmaceutical proteins are important to the control of their safety, purity, potency, stability, and overall quality. This chapter reviews the methodologies that are used to characterize important attributes of biopharmaceutical proteins. The methods used to characterize the primary and higher-order structures are discussed, including techniques to determine protein sequence, posttranslational modifications, folding, and aggregation. Aberrant results for those attributes may raise quality issues. Methods for protein concentration are described, including amino acid analysis, intrinsic protein absorbance, and colorimetric methods. This is followed by the determination of impurities, both product-related and process-related, which may compromise the safety of the protein therapeutics. Various assays, including bioassays and non-cell based binding assays for determining the functional activity of proteins, which may be indicative of potency, are described in this chapter. |
