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KMID : 0370220180620050325
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Yakhak Hoeji
2018 Volume.62 No. 5 p.325 ~ p.333
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Study on Establishment of the Korea National Standard Reference for Filgrastim
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Baek Joung-Hee
Yoo Ji-Hye
Hong Young-Ki
Park Tae-Hwan
Kang So-Yeong
Kim Min-Jung
Kim Ho
Woo Jeong-Nam
Heo Ji-Yeon
Park Ki-Dae
Eom Joon-Ho
Suh Soo-Kyung
Ahn Chi-Young
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Abstract
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We have established a new National Reference Standard(NRS) of filgrastim to be used for the quality management of domestic genetic recombinant drugs. Filgrastim is a recombinant human granulocyte colony stimulating factor(G-CSF) and one of the first-generation biosimilars used as the hematopoietic agent. At first, the candidate substance for the NRS was manufactured on consignment in accordance with the manufacturing process of filgrastim. The identity, purity, potency and protein contents of the candidate substance were assessed using electrophoresis, HPLC systems and a biological assay, which showed it was comparable to filgrastim in quality. In addition the stability test showed it was stable for 12 months. We performed a collaborative study with other institutes to endow it with the labelled protein content and potency values. From the data, it has been assigned with the protein content of 0.240 mg/mL(95% confidence intervals: 0.238~0.242 mg/mL) and the potency value of 2.94 × 107 IU per vial. We had finally enrolled it as the first Korean NRS of filgrastim as approved by Working Committee on Development of Testing and Inspection in Korea Ministry of Food and Drug Safety.
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KEYWORD
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filgrastim, national reference standard, quality test, potency
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