<p><strong>[2016 KFDC 법제학회 학회지-FDC법제연구 제11권 제2호, 183-192]</strong></p> <p> </p> <p style="text-align: center;"><span style="font-size: 12pt;"><strong>Surface Plasmon Resonance-Based Assay for Potency of a Monoclonal Antibody Drug</strong></span></p> <p style="text-align: center;"> </p> <p style="text-align: center;"><span style="font-size: 10pt;">Jounghee Baek1*, Heesung Shin1*, Hyoung Kyoung Choi2, Joon Ho Eom1,<br />Seung-rel Ryu1 and Soo Kyung Suh1†</span></p> <p style="text-align: center;"> </p> <p style="text-align: center;"><span style="font-family: courier new,courier,monospace;"><em>1Division of Advanced Therapy Product Research, National Institute of Food and Drug Safety Evaluation,</em></span><br /><span style="font-family: courier new,courier,monospace;"><em>Cheongju 28159, Republic of Korea</em></span><br /><span style="font-family: courier new,courier,monospace;"><em>2New Drug Development Center, KBIO Osong Medical Innovation Foundation, Cheongju 28160, Republic of Korea</em></span></p> <p style="text-align: left;"><strong><span style="font-size: 10pt;">Abstract </span></strong></p> <p style="text-align: left;"><span style="font-size: 10pt;">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.</span></p> <p style="text-align: left;"><span style="font-size: 10pt;"><br />Key words Surface Plasmon Resonance, monoclonal antibody drug, qualification, bioassay</span></p> <p style="text-align: left;"> </p> <p style="text-align: left;"><span style="color: #0000ff; font-size: 10pt;">............(Continue)</span></p> <p style="text-align: left;"> </p> <p style="text-align: left;"><strong><span style="font-size: 10pt;">※ 더 자세한 내용을 보시려면 아래의 <span style="color: #0000ff;">원문URL</span> 또는 <span style="color: #0000ff;">첨부파일</span>을 참고하시기 바랍니다.</span></strong></p>
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