R&D collaboration with The Danish State Serum Institute, Copenhagen, Denmark concerning pilot production of the beta-cell specific monoclonal autoantibody IC2. The pilot preparation has been tested in Paris and Copenhagen. The unique specificity of IC2 against the plasma membrane of insulin-producing beta-cells was confirmed.
Possible outsourcing contract with the biotech company Exbio, Prague, for a extensice large scale production of IC2 will be considered after a new pilot productions, antibody fragmentation, additional functional testing and eventual DNA-cloning of the specificity.
Immunosigns own in vitro production scheme uses INTEGRA double chamber cell culture flask, purification of rat IgM by monoclonal MARK-1 affinity chromatography, eventual antibody fragmentation, and appropriate quality and functional specificity control by flow cytometry.