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Establishment and verification of a method for detection of anti-drug antibody against recombinant human serum albumin
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Shu-han YANG1, Hai-yong LIU2, Xiang-yang JIA2, Li LIU1, Ping WANG3, Shu-fang LI4, Dong-sheng PAN1, Bo LI1
Chinese Journal of New Drugs | 2023, 32(18) : 1866 - 1873
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Chinese Journal of New Drugs | 2023, 32(18): 1866-1873
Establishment and verification of a method for detection of anti-drug antibody against recombinant human serum albumin
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Shu-han YANG1, Hai-yong LIU2, Xiang-yang JIA2, Li LIU1, Ping WANG3, Shu-fang LI4, Dong-sheng PAN1, Bo LI1
Affiliations
  • 1Beijing Key Laboratory of Non-clinical Safety Evaluation of Drugs, National Center for Safety Evaluation of Drugs, National Institutes for Food and Drug Control, Beijing 100176, China
  • 2Beijing Xinaijin Biotechnology Company, Beijing 100176, China
  • 3Shenzhen Protgen Ltd., Shenzhen 518048, China
  • 4Shanxi Key Laboratory of Drug Toxicology and Drug for Radiation Injury, China Institute for Radiation Protection Research, Taiyuan 030006, China
Published: 2023-09-30
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Objective: Drug resistance and endogenous cross-reactivity are the main factors affecting the detection of anti-drug antibody (ADA), so the establishment of method that can tolerate higher drug concentration and avoid endogenous cross-reactivity is a major problem to be solved in immunogenicity analysis. The aim of this study was to establish and verify a method for detection of ADA against recombinant human serum albumin (rHSA). Methods: Anti-rHSA antibody was extracted by acidification and enrichment with magnetic nanobeads and then detected using a bridging method. Finally, the established method was validated. Results: The recovery of the antibody was greater than 80% by using the established method. The sensitivity of the method could reach 0.5 μg·mL-1 and the intra- and inter-batch RSDs were less than 20%. In addition, the method could resist drug of up to 2 mg·mL-1. Conclusion: This study established a method for the detection of anti-rHSA antibody. The method has high antibody recovery and good performances of sensitivity and precision. It can also achieve mg-level drug-resistance and effectively remove the interference of endogenous substances, which can be applied for the detection of ADA, extraction of antibody drugs and further analysis of drug metabolism.

anti-drug antibody  /  drug resistance  /  cross reactions  /  serum albumin  /  enrichment and extraction
Shu-han YANG, Hai-yong LIU, Xiang-yang JIA, Li LIU, Ping WANG, Shu-fang LI, Dong-sheng PAN, Bo LI. Establishment and verification of a method for detection of anti-drug antibody against recombinant human serum albumin[J]. Chinese Journal of New Drugs, 2023 , 32 (18) : 1866 -1873 .
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Year 2023 volume 32 Issue 18
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  • Online Date：2026-03-05
  • Published：2023-09-30
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  • Accepted：2023-03-11
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Affiliations
    1Beijing Key Laboratory of Non-clinical Safety Evaluation of Drugs, National Center for Safety Evaluation of Drugs, National Institutes for Food and Drug Control, Beijing 100176, China
    2Beijing Xinaijin Biotechnology Company, Beijing 100176, China
    3Shenzhen Protgen Ltd., Shenzhen 518048, China
    4Shanxi Key Laboratory of Drug Toxicology and Drug for Radiation Injury, China Institute for Radiation Protection Research, Taiyuan 030006, China
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表12种不同金属材料的力学参数
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Family		 属数
Number of
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Number of
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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