Antibodies that neutralize cellular uptake of elosulfase alfa are not associated with reduced efficacy or pharmacodynamic effect in individuals with Morquio A syndrome
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- 作者：Andrew C. Melton ; AMelton@bmrn.com ; Russell K. Soon Jr. ; Troy Tompkins ; Brian Long ; Becky Schweighardt ; Yulan Qi ; Catherine Vitelli ; Anil Bagri ; Celeste Decker ; Charles A. O'Neill ; Stephen J. Zoog ; Lynne Jesaitis
- 关键词：TAb ; total antibody ; NAb ; neutralizing antibody ; LSD ; lysosomal storage diseases ; GAGs ; glycosaminoglycans ; ERTs ; enzyme replacement therapies ; rhGALNS ; recombinant human N-acetylgalactosamine-6-sulfatase ; 6MWT ; six minute walk test ; 3MSC ; three minute stair climb ; MVV ; maximum voluntary ventilation ; uKS ; urine keratan sulfate ; M6P ; mannose-6-phosphate ; CI-M6PR ; cation-independent mannose-6-phosphate receptor ; TQC ; titer quality control ; LQC ; low quality control ; HQC ; high quality control ; NPS
- 刊名：Journal of Immunological Methods
- 出版年：2017
- 出版时间：January 2017
- 年：2017
- 卷：440
- 期：Complete
- 页码：41-51
- 全文大小：1259 K
- 卷排序：440
文摘
A flow cytometry cell uptake assay for detecting and titering NAb is described. Neither NAb positivity nor titer correlates with elosulfase alfa efficacy. High concordance between in vitro binding and cell uptake NAb assay results.