The first assays to be manufactured include thyroid assays, tumour markers and fertility tests, and these will be followed in 2006 by cardiac, anaemia and specialist panels
Olympus Life And Material Science Europa says that production of the first immunoassay reagents for the AU3000i analyser has commenced in its extended Irish state-of-the-art facilities.
Olympus is already one of the world's leading clinical chemistry assay manufacturers, producing over one million kits per annum in the plant located near Limerick in south-west Ireland.
Having assay development and production in-house has long been recognised by Olympus as bringing major benefits in terms of performance, quality assurance and control, and customer confidence.
Therefore, when the strategic decision was taken to enter into the complex area of immunoassay, in-house development and manufacturing was identified as a key objective.
The first assays to be manufactured include thyroid assays, tumour markers and fertility tests.
These will be swiftly followed in 2006 by cardiac, anaemia and specialist panels.
Research and development was performed in the Olympus Immunodiagnostics R and D Centre in Paris, taking advantage of the latest developments in immunoassay technology.
The starting point was to produce a competitive range of robust, yet highly sensitive and specific assays, suitable for the new high throughput AU3000i immunoassay system.
Super-paramagnetic beads were chosen for the solid phase and chemiluminescence as the detection method.
Once the assays had been designed, the next step was to ensure high reproducibility in manufacturing and minimise the potential for damaging lot-to-lot variation.
This has been achieved by, among other things, the strictest quality control on assay components.
For example, consistently-sized one micron paramagnetic particles are used to create optimal assay characteristics.
This together with specially selected antibodies ensure highly specific and sensitive assays and excellent analytical performance.
Attention to detail is such that even the water is taken from Olympus's own wells on site.
Reagents are supplied in a ready-to-use, liquid stable format with unique 2D barcoding, which carries calibration curve values and all other data required for automated reagent management - lot number, expiry date, bottle ID and current reagent level.
Production is on customised filling lines installed in a new purpose built extension to the plant.
"Assay development and manufacture is, as we have learnt through our clinical chemistry experience, both an art and a science," says Peter Szillat, product manager, immunochemistry.
"Our R and D team in France and manufacturing personnel in Ireland have worked tirelessly on this project with outstanding results.
"In little over three years since the decision was initially taken to move into immunodiagnostics, we have now reached the position where the first reagents are being manufactured.
"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."
