IMMray™ microarray – production
Our quality systems are set to meet the general regulatory requirements for EN ISO 13485.
Production of IMMray™ microarray can be divided into three areas:
- The in-house production and purification of a new generation scFv antibodies
- The high-throughput printing of scFv antibodies on microarray chips also performed in-house
- The determination of the biomarker signature through cutting-edge bioinformatics
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- Antibody Production and Purification Process
Recombinant scFv antibodies are produced and purified in-house, using robotic systems and high-throughput processes. The antibodies come from a new generation of recombinant single chain fragment variant (scFv) antibodies from our own phage-display library.
Our library of recombinant scFv antibodies, specifically designed at the molecular level, gives us a reliable source of renewable high-quality recombinant scFv antibodies and ensures optimal chip functionality.
- Microarray Production
Recombinant antibody microarrays for multiplexed detection of immune regulatory proteins in complex biological samples i.e. IMMray™ technology, are produced in-house using a high-throughput non-contact robotic spotting system which prints ultra-low volumes (picoliters) of antibodies onto a solid support. The surface of the microarrays has been optimized for binding scFv antibodies.
The commercial IMMray™ microarray enables measurement of 10–35 clinically relevant biomarkers and is designed for 14 clinical samples.
Immunovia applies cutting-edge bioinformatic workflows and tools for analyzing microarray data, including data handling, normalization, biomarker signature identification and classification.
The microarray data generated is used to build Immunovia’s own predictive model based on biomarker signatures and the support vector machine (SVM) classification algorithm.
Biomarker signatures able to accurately classify/distinguish a disease state are identified through a stepwise biomarker/analyte selection process. Using an in-house developed backward elimination approach (and algorithm based on the SVM classification), one biomarker at a time is excluded in an iteration process, until the set of biomarkers showing the highest classification power between healthy and disease states is found. The selected biomarker signature is applied on the commercial IMMray™ microarray.
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