Olympus Opens New Immunoassay Facility

A plant located near Limerick in southwest Ireland is a major new facility where Olympus Life and Material Science Europa GmbH (Hamburg, Germany) will develop and manufacture immunoassays for the AU3000i analyzer.

The first assays to be manufactured include thyroid assays, tumor markers, and fertility tests. These will be followed in 2006 with cardiac, anemia, and specialist panels. The research and development was performed in the Olympus Immunodiagnostics R&D Center in Paris (France). The starting point was to produce a competitive range of robust but highly sensitive and specific assays, suitable for the company's new high throughput AU3000i immunoassay system.

Super-magnetic beads were chosen for the solid phase and chemiluminescence as the detection method. Once the assays were designed, the next step was to ensure high reproducibility in manufacturing and minimize the potential for damaging lot-to-lot variation. Olympus notes that this has been achieved by using the strictest quality control on assay components. For example, consistently-sized 1 micron paramagnetic particles are used to create optimal assay characteristics. This together with specially selected antibodies ensures highly specific and sensitive assays. Reagents are supplied in a liquid stable format with two-dimensional barcoding, which carries the calibration curve values and other data needed for automated reagent management.

"Assay development and manufacture is, as we have learned through our clinical chemistry experience, both an art and a science,” noted Dr. Peter Szillat, product manager, immunochemistry. "I am confident that when these reagents are launched with the Au3000i in Germany and France in a few months, customers will be equally impressed.” Olympus Life and Material Science Europa amalgamates the fields of microscopy and diagnostics.




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