Patent ID: 9567634
Date: 2017-02-14
CPC Classifications: C12Q

Claim:
1. A method for detecting and quantifying the cell response to transduction of a viral vector composition into eukaryotic target cells for further use in transgene transfer, comprising: (a) hybridizing and/or amplifying a polynucleotide of at least one biomarker selected from the group consisting of CXCL2 (SEQ ID NO:1) and EREG (SEQ ID NO:2) with nucleic acid primers/probes, or binding of an antibody, or antigen binding fragment thereof, specific to the protein encoded by said at least one biomarker to detect and quantify the expression level of said at least one biomarker in target cells having no contact with the viral vector composition; (b) separately transducing target cells with the viral vector composition and then either (i) hybridizing and/or amplifying a polynucleotide of at least one biomarker selected from the group consisting of CXCL2 (SEQ ID NO:1) and EREG (SEQ ID NO:2) with nucleic acid primers/probes, or (ii) binding of an antibody, or antigen binding fragment thereof to the protein encoded by said at least one biomarker, to detect and quantify the expression level of said at least one biomarker in the transduced target cells; and (c) comparing the level of expression of said biomarker(s) in (b) to the level of expression of biomarker(s) in (a), wherein a significant upregulation in biomarker expression level in (b) relative to (a) indicates that the quality of the viral vector composition is insufficient transfer for further use in transgene transfer, wherein the detection and quantification of the biomarker expression level are performed before the target cells reach confluency.