Bioanalytical Solutions

Bioanalysis is a specific discipline within analytical chemistry involved in the quantitative measurement of drugs, and/or their metabolites, in biological fluids (usually plasma, whole blood, serum or urine). The technique most commonly employed is based on a chromatographic separation of the molecules of interest and their subsequent detection using a tandem mass spectrometer (LC-MS/MS). Contract research organisations have traditionally been available to the pharmaceutical industry to perform routine steps in the drug development process and to enable them to manage their own internal capacity by outsourcing selected projects when the internal timelines are unacceptable with respect to the project requirements. In recent years, the drug development paradigm has been changing in a number of ways. This has been most noticeable in the reduction of the total number of new drug applications (NDAs) and therapeutic biologic applications (BLAs) that have been given approval. Linked to this has been a shift from new chemical entities (NCEs, or small molecules) towards new biological entities (NBEs, or large molecules) (1). To try to offset the increased cost and reduced ‘hit rate ’ in drug development, there has been an increased emphasis within pharmaceutical companies on reducing research and development (R&D) costs (2). This has led to a large increase in outsourcing to CROs and a change in the type of work being outsourced. If these trends continue, it is expected that pharmaceutical companies will lose some of their in-house expertise as they reduce or remove their internal analytical capabilities. It is already being observed that CROs are required to take up the mantle and, through strategic alliances and partnerships with the pharmaceutical companies, deliver the expertise and efficiencies needed. The CRO industry is therefore monitoring closely how pharmaceutical companies are changing and is reviewing how they can best serve their customers now and in the future. The focus within CROs needs to be on acquiring and maintaining regulatory and scientific knowledge, automating routine tasks and streamlining the method development process. The last of these objectives has always been seen as a major bottleneck in bioanalysis by both CROs and the pharmaceutical industry