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KMID : 1142220160110020183
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Regulatory Research on Food, Drug & Cosmetic
2016 Volume.11 No. 2 p.183 ~ p.192
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Surface Plasmon Resonance-Based Assay for Potency of a Monoclonal Antibody Drug
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Baek Joung-Hee
Shin Hee-Sung
Choi Hyoung-Kyoung
Eom Joon-Ho
Ryu Seung-Rel
Suh Soo-Kyung
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Abstract
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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.
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KEYWORD
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Surface Plasmon Resonance, monoclonal antibody drug, qualification, bioassay
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