The analysis of protein pharmaceuticals: near future advances.

The analysis of protein pharmaceuticals currently involves a complex series of chromatographic, electrophoretic, spectroscopic, immunological and biological measurements to unequivocally establish their identity, purity and integrity. In this review, I briefly consider the possibility that at least the functional identity and integrity of a protein drug might be established by either a single analysis involving X-ray diffraction, NMR or mass spectrometry, or by a chromatographically based multi-detector system in which a number of critical parameters are essentially simultaneously determined. The use of a protein standard to obtain comparative measurements and new advances in the technology of each of these methods is emphasized. A current major obstacle to the implementation of these approaches is the frequent microheterogeneity of protein preparations. The evolution of biological assays into measurements examining more defined intracellular signal transduction events or based on novel biosensors as well as the analysis of vaccines is also briefly discussed.