Abstract: The invention relates to a process for detecting or determining a C-peptide-containing impurity in a sample of recombinantly produced human insulin or a derivative thereof, by a non-radioactive assay, comprising the steps: (a) preparing a sample of recombinantly produced human insulin or a derivative thereof; (b) mixing the samples with dilution buffer; (c) adding a tracer to mixture (b); (d) adding antibody specific for the C-peptide impurity to mixture (c); (e) adding “C-peptide second antibody bead” having at least one label to mixture (d); and (f) detecting or determining the presence of the C-peptide-containing impurity.

Abstract: Monoclonal antibodies for selective immunological determination of high molecular weight, intact laminin forms in body fluids. The present invention relates to monoclonal antibodies for the selective immunological determination of high molecular weight forms of laminin in body fluids, to a process for preparing these antibodies, and to their use for diagnosing diseases. The antibodies according to the invention preferably bind to intact, native laminin, in particular to the structures of the laminin P1 domain of the laminin which are folded in a native manner.

Abstract: Monoclonal antibodies directed to the laminin P1 domain for selective immunological determination of native, high molecular weight, intact laminins in body fluids; a process for preparing these antibodies; and their use for diagnosing diseases. These antibodies preferably bind to intact, native laminin, in particular to the structures of the laminin P1 domain of laminin which are folded in a native manner.