유전자재조합 필그라스팀 국가표준품 확립 연구

• 영문명: Study on Establishment of the Korea National Standard Reference for Filgrastim
• 발행기관: 대한약학회
• 저자명: 백정희(Joung Hee Baek) 유지혜(Ji hye Yoo) 홍영기(Young Ki Hong) 박태환(Tae Hwan Park) 강소영(So yeong Kang) 김민정(Min Jung Kim) 김 호(Ho Kim) 우정남(Jeong nam Woo) 허지연(Ji yeon Heo) 박기대(Ki Dae Park) 엄준호(Joon Ho Eom) 서수경(Soo Kyung Suh) 안치영(Chi young Ahn)
• 간행물 정보: 『약학회지』제62권 제5호(2018년), 325~333쪽, 전체 9쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2018.10.30

영문 초록

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.

목차

서 론(Introduction)

연구 방법(Experimental Methods)

연구결과 및 고찰(Results and Discussion)

결 론(Conclusion)

감사의 말씀(Acknowledgments)

References

키워드

filgrastim national reference standard quality test potency