An innovative 125-I-based process that reduces development time and costs for immunodiagnostic devices

Kurzfassung

A UK company has developed a methodology that enables the visualization and quantification of critical components for optimization of development of immunoassay devices, leading to significantly reduced development time and costs. The same procedures may be used for Quality Control during the production of these devices, providing unequivocal quantitative results. The company is looking for license agreements, technical collaboration or commercial agreements with technical assistance.

Details

There is an increasing market for diagnostic devices based on the immuno-detection of specific antigens using targeted antibodies. These include, for example, point of care devices for the detection of bacteria (e.g. Salmonella spp, E.coli, Mycobacterium tuberculosis, etc) and devices for home pregnancy testing.

One of the key steps in the development and production of these devices is the optimization of the concentrations of the critical components, particularly the antibodies used for the detection of the targeted antigens.

A UK biotechnology company has developed an in-house process for the optimization of the concentration of antibodies in situ on the plastics, nitrocellulose or other substrate support materials used for the device in question. The process has been validated through the development of specific diagnostic devices in collaboration the company’s customers where the process has led to significantly reduced development time and costs, and an improved quality of product due to the sensitivity of the assay used which has helped lead to greater precision in the quantification of the antibody components.

The process is based around know-how and procedures developed in-house using 125-I labeled materials. The signal generated by 125-I is unaffected by factors such as temperature and pH making the technique particularly robust. Processing times are reduced (compared to other systems) due to the nature of the 125-I signal which can be easily measured in a gamma counter and the fact that only one incubation step is required contrasting for example with enzyme labeling techniques. Moreover, unlike other labeling systems (such as fluorescence systems) there is no background signal from the plastics or other support materials allowing a high signal-to-noise ratio and thus providing increased sensitivity. The technique may be used to visualize as little as 10 – 100 picograms of antibody.

The company is looking for partners who are interested in accessing the novel process through a commercial agreement with technical assistance. The company would offer a fully flexible approach tailored to the partner’s specific requirements. The company is also interested in technical collaboration with a view to joint further development, adaptation to specific needs of prospective partners and evaluation of the methodology for new applications.

Innovative Aspects:
The main advantages of the process developed by the UK company are the sensitivity and accuracy of the methodology compared to other current procedures. The procedure helps to speed up the optimization processes involved in production of immunodiagnostic devices, reducing development time and saving costs.

Further advantages include:

•Experimental results are available quickly raising the possibility of interpretation of results and subsequent experimentation in one time slot.
•The use of the 125-I methodology in QC procedures provides a robust and quantifiable system potentially capable of rapid identification of batch failures during production runs.
•The company itself has a dedicated ‘hot lab’ radioiodination suite and a spacious low level laboratory available for supervised experimentation. These facilities and associated technical will be made available to prospective partners.