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Setting Up and Running a Protein Microarray Core Facility
Microarray manufacturing is an area that is plagued with numerous technical challenges due, in part, to the complexity of the systems involved and to the variety of proteins and potential assays used.
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In-line Processing Trends for Lateral-flow Immunoassay Manufacturing
This article reviews current trends in manufacturing processes that IVD companies are implementing to achieve higher performance reproducibility from test to test, as measured by coefficient variability (CV), and better efficiency for high volume manufacturing. This article also focuses on processes such as application of various chemistries onto supporting materials, drying of such porous materials, and laminating and cutting all processed materials into finished test strips that are adequate for LFIAs.
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Low Volume Dispensing of Biomaterials for Biosensor and other Related Diagnostic Tests
Following advances in microelectronics, biosensor designs are becoming increasingly complex, and focused on miniaturization. The demand for simultaneous measurement of multiple analytes has made sensor arrays more the norm than the exception. As a result of this demand, and the advancing capabilities of patterning technologies, research and development programs aimed at sensor arrays containing tens to thousands of individual sensors in devices on the order of a square centimeter are underway. Fabrication of these devices typically requires reagent-dispensing approaches capable of delivering volumes ranging from the low microliters to picoliters. Reductions in volume reduce cost of expensive reagents, increase surface dependant reaction rates, and promote adoption of multiplexed diagnostic devices. These benefits have seen low volume dispensing applied to various research areas including Biosensors, Biochips, Protein Arrays, and Cell Arrays. Dispensing systems used must be compatible with a wide range of reagent classes, including organic solvents, biological fluids, polymeric solutions, as well as the traditional combination of buffer and enzymes. Systems must be robust enough to produce hundreds of thousands to millions of dispenses with a high level of precision and accuracy. Lastly these systems must function in a production environment using less skilled labor and also subject to rigorous regulatory requirements.
This article reviews process parameters that impact accuracy, precision and reproducibility as measured by coefficient of variation (CV) of drop volume. Reduced variability is the key to minimizing rejected parts and other manufacturing costs, as well as to gain acceptance by the medical community and patients. Variability can be minimized at the level of chemical formulation, inclusion of appropriate electrode controls and regular re-calibration by specialists or patients. However, reduced variability in dispensed volumes remains essential.
(Paper forthcoming)