York Bioanalytical Unveils Immunoassay Service
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York Bioanalytical Solutions (YBS) has announced the launch of its immunoassay service for the bioanalytical support of large molecule developments and the measurement of biomarkers.
YBS is also announced the key appointment of Dr Vivian Willson to lead its in-house immunoassay group.
This service will utilise the systems currently in place at YBS. This will ensure that sponsors will receive the same high quality service and on-time delivery that they have come to expect from YBS.
The advent of biotechnology to produce biopharmaceuticals has transformed the approach to the treatment of diseases, and the rapidly growing sector of the pharmaceutical industry (estimated as twice the rate of that seen for small molecules over the next five years), is the development of biopharmaceuticals.
This will build upon the over 105 biopharmaceuticals that had already been approved for clinical use as of December 2005.
An additional factor in YBS’ decision to launch its immunoassay service at this time is the growing requirement for the analysis of ‘biomarkers’ to support clinical development of therapeutics of all types.
Many of these biomarkers are endogenous peptides or proteins. From a bioanalytical perspective, conventional, chromatographic analysis methods are poorly suited to the analysis of biopharmaceuticals and biomarkers, and immunoassay formats have made an impressive resurgence over recent years.
The use of commercially available or custom prepared ‘kits’ appears to indicate that immunoassay should be a much simplified approach to bioanalysis.
However, injudicious use of kits can present problems to scientists responsible for clinical assay support; there have been a number of reports of established kit methodologies generating divergent results when applied to the same biofluid samples.
The YBS response to these issues has been to develop an in-house immunoassay group capable of ensuring that the methodologies developed are appropriate and that adequate validations, including cross-comparisons between different methods are made.
Dr Vivian Willson, who heads up this group, provides expert input to clinical study design, the selection of appropriate panels of biomarkers, and in the interpretation of data obtained.
Dr Wilson has been responsible for the establishment of a variety of now widely adopted techniques such as ELISA, IEMA and DELFIA in various major laboratories.