PubMed · 8668680
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C K Carrico. 1996. AAPS/USP Workshop on Dissolution Calibration and Testing.. https://doi.org/10.1023/a%3A1016052527777
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Analytical ultracentrifugation (AUC) has reemerged as a powerful technique for protein characterisation. We report the pivotal role sedimentation equilibrium AUC has played in the development of macrophage inflammatory protein-1 alpha (MIP-1 alpha) as a protein therapeutic. MIP-1 alpha has potential clinical applications in cancer but its clinical use is limited, since it associates to form large insoluble aggregates in physiological buffers. Using AUC as a screening technique, we have produced a biologically active variant of MIP-1 alpha, BB-10010, which has a reduced tendency to aggregate in physiological buffers. The aggregation of protein based pharmaceuticals is routinely monitored by size exclusion chromatography (SEC). Comparison of the data acquired by SEC and AUC, demonstrates that owing to the complexity of BB-10010, AUC analysis is required in addition to SEC to provide a rigorous characterisation of molecular association. This work has been extended to include the use of AUC as an analytical tool to monitor the quality of BB-10010 during formulation and stability studies.
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Several, mainly macroeconomic factors are putting increasing pressure on health care budgets. These budget constraints lead to cost containment measures by all partners involved in health care. Pharmacotherapy, too, is facing an increasing involvement in health economics or outcomes research. This paper will first deal with some basic principles of pharmacoeconomics. The relationship with pharmacokinetics and biopharmaceutics has perhaps not yet been an issue as such, though it should be pointed out that they play a key role in the efficiency of drug use. Many of the basic R&D investments aimed at developing cost-effective medicines should be founded on adequate pharmacokinetics. Also a rational use of drugs in practice can be achieved by adequate drug monitoring, resulting in a gain in cost-effectiveness. Last but not least, pharmacokinetics and biopharmaceutics can offer opportunities for the rational use of new or existing pharmaceutical products and for the maintenance of a sufficient market share. Some of these more technical aspects are discussed in the second part of this presentation.