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

Abstract

Aim: 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. Results: 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. Conclusion: 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.

Keywords::

• ADA
• correlational analysis
• idursulfase
• MPSII
• NAb

Financial & competing interests disclosure

Correlation sample analysis using ECL bridging methods, updated NAb activity method and updated IgE ADA assay was conducted at Covance (formerly Tandem, West Trenton, NJ, USA) under the project manager, Christine Rivera. The study was sponsored by Shire. All authors are employees of Shire or were employees at the time of the study and own shares in the company. T McCauley is currently employed at RaNA Therapeutics, Cambridge, MA USA. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. Serum samples tested in this study were collected as a part of immunogenicity monitoring from patients receiving commercially prescribed Elaprase^® under physicians’ care.

Acknowledgements

The authors would like to thank patients, their families and physicians.