| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 8419107 | Journal of Immunological Methods | 2011 | 9 Pages |
Abstract
⺠Velaglucerase alfa and imiglucerase are therapies for type 1 Gaucher disease. ⺠We developed assays to compare antibody response to these two replacement enzymes. ⺠Screening, confirmatory, isotyping, and neutralizing activity assays were developed. ⺠State-of-the-art methods and the latest guidance were used to validate the assays. ⺠The assays facilitate direct comparison of antibody responses to the two enzymes.
Keywords
RSDFDAHBS-EPVelaglucerase alfaLOQNaBECLCPMDPBSEMABSAbovine serum albuminAnti-drug antibodyNeutralizing antibodiesEuropean Medicines agencyElectrochemiluminescencerelative standard deviationstandard deviationimmunoglobulin ImigluceraseGaucher diseaseAssayLOD یا Limit of detectionFood and Drug Administrationcounts per minutelimit of quantificationlimit of detectionresonance unitsADAAntibody
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Authors
Márcia Séllos-Moura, Samad Barzegar, Luying Pan, Philip Shi, Susan Oommen, Judith Durant, Juan A. Ruiz,