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국내 허가된 유전자재조합의약품 품질시험에 사용되는 전하변이체 분석법 조사연구
엄준호(Joon Ho Eom),백정희(Jounghee Baek),홍영기(Young Ki Hong),손애라(Aera Son),강소영(Soyeong Kang),오호경(Hokyung Oh),김민정(Min-Jung Kim),우정남(Jeong-Nam Woo),안치영(Chiyoung Ahn) 대한약학회 2020 약학회지 Vol.64 No.1
Analysis on approval documents of recombinant DNA-derived biopharmaceuticals (172 items) marketed in Korea showed as followed. First of all, antibody drugs are about 37% among the biopharmaceuticals and most of antibodies as a major ingredient (about 92%) are humanized or human type. Second, charge variant assays using in quality (purity) test are distinctly different between antibody drugs and non-antibody drugs. The former prefer CEX and cIEF, the latter IEF and CZE. The preference difference may be related to size and complexity of target molecules. Third, the result of analysis on usage of 4 assays (CEX, CZE, IEF, and cIEF) in accordance with approval period indicated that cIEF usage got increased since 2010 and was about 50% after 2015. And finally, acceptance criteria of charge variant assays showed a few distinguished patterns independent of drug products. In the light of these facts, whether or not to establish a charge variant method and acceptance criteria as a quality test, and which method to use may depend on the characteristics of the product and analysis conditions of other manufacturers. In particular, in biopharmaceuticals that contain polymer proteins as the main component, such as antibodies, charge variant analysis is important, and the use of modern analytical methods such as the icIEF method is expected to increase.
VO, Thuy T. B.,JUNG, Eui-Man,DANG, Vu Hoang,JUNG, Kikyung,BAEK, Jounghee,CHOI, Kyung-Chul,JEUNG, Eui-Bae Society for Reproduction and Development 2009 Journal of Reproduction and Development Vol.55 No.4
<P>Endocrine disruptors (EDs) with androgenic and anti-androgenic effects may alter reproductive function by binding to androgenic receptors (AR) and inducing or modulating AR-dependent responses in the male reproductive system. However, the molecular mechanism(s) underlying these events remains unclear. In the present study, pregnant Sprague Dawley (SD) rats were treated with testosterone propionate (TP), flutamide (Flu) and di-(2-ethylhexyl) phthalate (DEHP) from gestation days (GD) 11 to 21. Interestingly, maternal exposure to Flu or DEHP caused fluctuations in the neonatal levels of serum testosterone (T) and luteinizing hormone (LH). Serum testosterone and LH were upregulated by Flu, but these hormones were down-regulated by DEHP. The anogenital distances (AGD) of male newborns were determined at post-neonatal days (PND) 1, 21 and 63. Male rats treated prenatally with DEHP (100 mg/kg mother's body weight) or Flu showed an AGD shorter than that of control rats. At PND 63, sperm concentration, viability and motility were reduced in the maternal DEHP and Flu-treated groups. The numbers of seminiferous tubules were reduced in the Flu and DEHP-treated offspring when compared with the vehicle- and TP-treated groups, and the tubules of the testes at PND 63 were disrupted by a high dose of Flu. In addition, we found differential gene expression patterns by microarray analysis following ED exposure, particularly in sex determination-related genes. Although Flu and DEHP are considered to be identical with regard to their anti-androgenic effects, their effects on developing male reproductive organs were distinct, suggesting that Flu competes with endogenous T, while DEHP influences a different step in androgenesis.</P>