Establishment of anti CD80 drug binding activity method based on SPR technology

Published on Nov. 18, 2023Total Views: 1097 times Total Downloads: 352 times Download Mobile

Author: Shan-Shan DONG ¹ Zhuo-Wei SHI ¹  Xu-Hua DUAN ^1, ²  Hong SHAO ¹ Gang CHEN ¹

Affiliation: 1. Shanghai Institute for Food and Drug Control, NMPA Key Laboratory for Quality Control of Therapeutic Monoclonal Antibodies, Shanghai 201203, China 2. Institutes of Biomedical Sciences, Fudan University, Shanghai 200032, China

Keywords: Surface plasmon resonance Anti-CD80 biomedicines Binding activity CM5 chip

DOI: 10.12173/j.issn.1008-049X.202209176

Reference: Shan-Shan DONG, Zhuo-Wei SHI, Xu-Hua DUAN, Hong SHAO, Gang CHEN.Establishment of anti CD80 drug binding activity method based on SPR technology[J].Zhongguo Yaoshi Zazhi,2023, 26(10): 74-81.DOI: 10.12173/j.issn.1008-049X.202209176.[Article in Chinese]  Copied

Abstract
Full-text
References

Abstract

Objective Based on surface plasmon resonance (SPR) technology, to established the method of anti-CD80 biotechnological drug binding activity, and to carry out the methodology validation and sample determination of the established method.

Methods An appropriate binding activity method was established by optimizing the test parameters, and a suitable data analysis model was selected to validate the established method.

Results Through screening various conditions and durability test, the test parameters of the method were determined as follows: the ligand fixation condition was acetate buffer with pH of 5.0, the fixed amount was 400-5 000 RU, the binding and dissociation rate was 10-50 µL·min^-1, the chip regeneration condition was pH 4.0 citrate buffer (10 mmol·L^-1 sodium citrate, 100 mmol·L^-1 NaCl), the response parameter was the relative response value of steady state (the average response value within 10 seconds after the end of the injection), and the data model was a four-parameter model. According to the above parameters, an anti-CD80 biotechnological drug binding activity method based on SPR technology was established. The verification results are as follows: the determination coefficient of the linear regression equation was 0.999 4, the average relative bias of the relative potency determination value of each potency level was 0.66%-0.64%, the slope of the linear regression equation was 0.986 7, the geometric coefficient of variation of six independent tests for each potency level was 0.7%-1.5%, and the range was 64%-156%. All the verification indicators met the relevant verification requirements, and the specificity results were very well. The established binding activity method was applied to anti-CD80 biotechnological drugs, and the relative potency of binding activity was measured to be 100%.

Conclusion In this study, a method of anti CD80 biotechnology drug binding activity based on surface plasmon resonance technology is established by optimizing the test conditions, and this method has strong specificity, good repeatability and high accuracy.

Full-text

Please download the PDF version to read the full text: download

References

1.王鸣人, 段徐华, 邵泓, 等. 表面等离子共振(SPR)技术在生物药物质量控制中的应用前景[J]. 中国药师, 2020, 23(11): 2257-2260. [Wang MR, Duan XH, Shao H, et al. Application prospect of surface plasmon resonance technique in quality control of biopharmaceutical products[J]. China Pharmacist, 2020, 23(11): 2257-2260.] DOI: 10.3969/j.issn.1008-049X.2020.11.041.

2.Zeng S, Baillargeat D, Ho H, et al. Nanomaterials enhanced surface plasmon resonance for biological and chemical sensing applications[J]. Chem Soc Rev, 2014, 43(10): 3426-3452. DOI: 10.1039/C3CS60479A.

3.Jing J, Wang Q, Zhao W, et al. Long-range surface plasmon resonance and its sensing applications: a review[J]. Opt Lasers Eng, 2019, 112(SI): 103-118. DOI: 10.1016/j.optlaseng.2018.09.013.

4.中国药典2020版. 四部[S]. 2020: 334, 530.

5.USP43rd eds.NF38[S]. 2020: 7773.

6.JP 14th eds[S]. 2016: 2656.

7.Bernett MJ, Chu SY, Leung I, et al. Immune suppression in cynomolgus monkeys by XPro9523: an improved CTLA4-Ig fusion with enhanced binding to CD80, CD86 and neonatal Fc receptor FcRn[J]. MAbs, 2013, 5(3): 384-396. DOI: 10.4161/mabs.23976.

8.Hou TZ, Qureshi OS, Wang CJ, et al. A Transendocytosis model of CTLA-4 function predicts its suppressive behaviour on regulatory T cells[J]. J Immunol, 2015, 194(5): 2148-2159. DOI: 10.4049/jimmunol.1401876.

9.朱磊. 重组CTLA4-Ig融合蛋白的糖基化修饰分析及其对稳定性和功能影响的研究[D]. 上海: 第二军医大学, 2016.

10.Larsen CP, Pearson TC, Adams AB, et al. Rational development of LEA29Y (belatacept): a high-affinity variant of CTLA4-Ig with potent immunosuppressive properties[J]. Am J Transplant, 2005, 5(3) : 443-453. DOI: 10.1111/j.1600-6143.2005.00749.x.

11.Nguyen HH, Park J, Kang S, et al. Surface plasmon resonance: a versatile technique for biosensor applications[J]. Sensors, 2015, 15(5): 10481-10510. DOI: 10.3390/s150510481.

12.Chen SM, Liu Y, Yu QX, et al. Self-referencing SPR biosensing with an ultralow limit-of-detection using longwavelength excitation[J]. Sensors and Actuators B: Chemical, 2021, 327: 128935. DOI: 10.1016/j.snb.2020. 128935.