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KMID : 0380020060210030212
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Korean Journal of Biotechnology and Bioengineering
2006 Volume.21 No. 3 p.212 ~ p.219
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Development of an Enzyme-Linked Immunosorbent Assay Method for Residual Host Cell derived Proteins in Recombinant Antibody Drug Production
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Joung Chan-Hi
Son Young-Su
Kim Hyun-Il
Park Heung-Rok
Lim Sang-Min
Koo Yoon-Mo
Lee Yong-Yoon
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Abstract
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The purpose of this study was to develop a assay system of host cell-derived residual proteins in final pharmaceutical products. Accurate and simple assay system for host cell-derived proteins (HCPs) is very important test item in pharmaceutical qualification control. In this study, methods for quantification of residual HCPs in recombinant anti-GPIIbIIIa antibody were developed using a process-specific immunoligand assay which was based on the Enzyme linked Immunosorbent assay (ELISA) system. The assay had a detection limit of 10.8 ng/ml of HCPs with a product concentration of 1 mg/ml. The practical implication of these results is that the developed ELISA system can be used for HCPs qualification control and this system will be applicable to develop another ELISA system of different antibody drug.
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KEYWORD
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Host cell derived proteins, ELISA system, anti-GPIIbIIIa antibody
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