Immunologic assay to determine C-peptide containing...

Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...

Reexamination Certificate

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C435S007930, C435S007940, C435S007950, C436S015000, C436S086000

Reexamination Certificate

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09695919

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.

REFERENCES:
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patent: 6444641 (2002-09-01), Flora
patent: 6635745 (2003-10-01), Sedrani et al.
patent: 0 484 961 (1992-05-01), None
Campbell Alice section 1.3.4. p. 29; Monoclonal Antibody Technology (1984) Elsevier Science Publishers).
Naithani et al. Syntheses of monkey C-peptide derivatives Fed. Rep. Ger. International Congress Series (1979) 468: 94-98.
Iizuka et al. An Improved method for determination of human C-peptide in serum and urine. Biomedical Research (1990) 11: 417-423.
International Search Report to PCT/EP 00 10482 (May 7, 2001).
Derwent Abstract—WO 98/59246, abstract only.
V.K. Naithani & L.G. Heding, “Synthesis of Monkey C-Peptide Derivatives,”Proceedings of the Symposium on Proinsulin, Insulin, and C-Pepetide, Tokushima, Japan, Jul. 12-14, 1978, S. Baba et al., Eds., Exerpta Medica, Amsterdam-Oxford, pp. 94-98 (1979).

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