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Bioanalysis. 2015;7(3):285-94. doi: 10.4155/bio.14.245.

Feasibility of immuno-PCR technology platforms as an ultrasensitive tool for the detection of anti-drug antibodies.

Author information

1
Translational Science & Technology, Biogen Idec, Inc., 14 Cambridge Center, Cambridge, MA 02142, USA.

Abstract

AIM:

During the early clinical development of a receptor-IgG1 fusion protein (Drug X), a risk based strategy was utilized to evaluate immunogenicity from Phase I through Proof of Concept clinical studies.

MATERIALS & METHODS:

Three different technology platforms, enzyme-linked immunosorbant assay, electrochemiluminescent assay and newly emerging immuno-PCR were utilized for evaluation of immunogenic response.

RESULTS:

An ELISA with adequate sensitivity but significant drug interference was replaced by electrochemiluminescent method with improved drug tolerance; however, an inverse correlation was observed between the administered dose and the incidence of anti-drug antibodies. Further evaluation of an immuno-PCR showed reduced drug interference enabling the detection of anti-drug antibodies in the presence of excess amount of Drug X.

CONCLUSION:

Immuno PCR assay proved to be a feasible platform for anti-drug antibody characterization.

PMID:
25697187
DOI:
10.4155/bio.14.245
[Indexed for MEDLINE]

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