A comparison study of bioanalytical methods for detection and characterization of anti-velaglucerase alfa antibodies. (May 2017)

• Record Type: Journal Article
• Authors: Najarian, Diana R; Hilton, Kelly; McCauley, Thomas; Qiu, Yongchang
• Is Part Of: Bioanalysis. Volume 9:Number 9(2017)
• Page Start: 775
• Page End: 786
• Publication Date: 2017-05
• Subjects: ADAs -- antidrug antibodies -- comparative analysis -- Gaucher disease -- NAbs -- neutralizing antibodies -- velaglucerase alfa; Drugs -- Analysis -- Periodicals; 615.19005
• DOI: 10.4155/bio-2016-0274
• Languages: English
• ISSNs: 1757-6180

Abstract

Aim: To provide more efficient and timely immunogenicity testing service to support routine patient care, the original complex testing algorithm for evaluation of anti-velaglucerase alfa antibodies has been simplified and individual methods (screen, confirm, titer, neutralizing antibody [NAb] and IgE) have been redeveloped/optimized and validated.Results: To compare the performance of different methods, 50 velaglucerase alfa-treated patient samples were analyzed using both old and new methods for the presence of antidrug antibodies (ADAs) and 31 ADA-positive samples were analyzed for neutralizing capacity. The ADA and NAb statuses are almost identical from both methods and both ADA and NAb titer results are highly correlated with a Spearman's correlation of 0.96 and 0.86, respectively.Conclusion: The original and new testing methods can be considered interchangeable for the measurement of total and neutralizing anti-velaglucerase alfa antibodies.