Earticle

초록

영어

Therapeutic monoclonal antibodies (mAbs) are not only actively developed, but also currently lead the biopharmaceutical market. Furthermore, the expiration of the blockbuster mAbs patent has recently increased, and many new biosimilars are under development. Sophisticated test methods for the qualification of such biosimilars are required. Bioassays in vitro or in vivo for their potency test can cause many disadvantages, for example, it takes long time, more than 2 days and requires the well-trained technicians to reduce data variations. Herein, to overcome the disadvantages we developed Surface Plasmon Resonance (SPR)-based assay for potency of mAbs to assess commercial mAbs, and performed other conventional tests including cell-based assay. Our SPR-based analysis fulfilled the method validation requirements such as specificity, precision, accuracy and linearity. The SPR-based assay was found to be more accurate for qualifying mAb than conventional tests. In conclusion, we suggest the SPR-based assay is clearly applicable to biopharmaceutical products quality management and provides a potential alternative to conventional analytical procedures for mAbs.

목차

Abstract
 I. Introduction
 II. Materials and Methods
  1. Cell-based Bioassay
  2. Size exclusion High performance liquid chromatography analysis
  3. Surface Plasmon Resonance (SPR) analysis
  4. Method validation for SPR-based assay
  5. Heat-treatment of monoclonal antibodies
  6. Statistical analysis
 III. Results
  1. Heat-treatment for qualification of monoclonal antibodies
  2. Cell-based Bioassay of anti-TNF-α monoclonal antibodies
  3. Size Exclusion-High Performance Liquid Chromatography analysis of monoclonal antibodies
  4. Surface Plasmon Resonance analysis of monoclonal antibodies
 IV. Discussion
 V. Conclusion
 Acknowledgements
 References

키워드

저자

• Jounghee Baek [ Division of Advanced Therapy Product Research, National Institute of Food and Drug Safety Evaluation, Cheongju 28159, Republic of Korea ]
• Heesung Shin [ Division of Advanced Therapy Product Research, National Institute of Food and Drug Safety Evaluation, Cheongju 28159, Republic of Korea ]
• Hyoung Kyoung Choi [ Drug Development Center, KBIO Osong Medical Innovation Foundation, Cheongju 28160, Republic of Korea ]
• Joon Ho Eom [ Division of Advanced Therapy Product Research, National Institute of Food and Drug Safety Evaluation, Cheongju 28159, Republic of Korea ]
• Seung-rel Ryu [ Division of Advanced Therapy Product Research, National Institute of Food and Drug Safety Evaluation, Cheongju 28159, Republic of Korea ]
• Soo Kyung Suh [ Division of Advanced Therapy Product Research, National Institute of Food and Drug Safety Evaluation, Cheongju 28159, Republic of Korea ] Corresponding author

참고문헌

발행기관

간행물

표지보기 관심저널 등록

• 간행물명

  KFDC규제과학회지(구 FDC법제연구) [Regulatory Research on Food, Drug and Cosmetic]

• 간기

  반년간

• pISSN

  2799-8940

• 수록기간

  2006~2025

• 십진분류

  KDC 518 DDC 615