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A Comparison Study of Bioanalytical Methods for Characterization of Anti-Idursulfase Antibodies

Authors: Luying, Pan; Kelly, Hilton; Marie, Nadeau; Thomas, McCauley; Yongchang, Qiu;

A Comparison Study of Bioanalytical Methods for Characterization of Anti-Idursulfase Antibodies

Abstract

Legacy methods with complex testing scheme for characterization of anti-idursulfase antibodies (ADA) were simplified and optimized in order to meet current regulatory guidance and provide more timely and cost-effective support for routine patient care.To compare the performance of the original and updated methods, patient samples receiving commercially prescribed Elaprase treatment were analyzed by both test methods. The ADA and neutralizing antibody results obtained by both methods were highly correlated and the updated method had an overall higher ADA and neutralizing antibody positive rates and higher ADA titers.The updated methods and test schemes are much simpler, more sensitive, but are also highly comparable with the original methods for the measurement of total and neutralizing ADA.

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Keywords

Cost-Benefit Analysis, Humans, Iduronate Sulfatase, Antibodies, Neutralizing, Blood Chemical Analysis

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
1
Average
Average
Average
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