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- E-ISSN 2288-8985
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Study on stability test of in process sample of recombinant Protein A
Analytical Science and Technology / Analytical Science and Technology, (P)1225-0163; (E)2288-8985
2012, v.25 no.6, pp.483-491
https://doi.org/10.5806/AST.2012.25.6.483
(Advanced Protein Technologies(Co.))
&
(2012). Study on stability test of in process sample of recombinant Protein A. Analytical Science and Technology, 25(6), 483-491, https://doi.org/10.5806/AST.2012.25.6.483
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Abstract
본 연구는 재조합 단백질 A를 생산하기 위한 정제공정 즉, 생산공정은 양이온교환칼럼(SP)과 음이온교환칼럼(Q)을 통하여 정제한 후 최종 재조합 단백질 A를 생산하게 되는데, 공정단계별로 생산된 시료를 바로 다음단계 공정으로 가지 못하는 경우 보관을 하는데 있어 안정성 확보 문제를 가지고 있다. 이에 본 연구에서 생산공정에서 생산된 시료를 보관 했을때 적정 보관조건과 시간을 알아보고자 하는데 목적이 있다. 즉, 공정시료의 저장방법 및 저장기간 설정과 경시변화에 따른 품질의 안정성의 평가를 목적으로 한다. 실험항목은 엔도톡신, SDS PAGE, HPLC 순도 그리고 농도이다. 실험결과 양이온교환칼럼 통과 후 냉장(4 oC), 실온보관에서 SDS PAGE는 major band, 엔도톡신은 5.0 Eu/mg이하, 농도에서는 평균8.21~8.24 mg/mL, RSD% 0.10~0.62%, 그리고 HPLC 순도 214 nm에서 평균 99.24~99.37%, RSD%0.22~0.29%, 280 nm에서 평균 89.72~89.80%, RSD% 0.62~1.26%로서 다소 안정된 결과를 나타내었다. 음이온칼럼통과 후 냉장(4 oC), 실온보관에서 SDS PAGE major band, 엔도톡신 0.5 Eu/mg이하, 농도는평균 5.59 mg/mL, RSD% 0.03~0.10% 그리고 HPLC 순도 214 nm에서 평균 99.74%, RSD% 0.10~0.11%,280 nm에서 평균 96.16~96.85%, RSD% 0.72~1.13%의 결과를 보였다. 상기의 실험결과로 재조합 단백질A 제조공정시료의 실온과 4 oC에서 7~8 일 그리고 20~21 일 보관은 물질분해 특성이 없이 안정성이 확보 되었다는 결론을 얻을 수 있었다.
- keywords
- recombinant protein a, stability, endotoxin, SP, Q, HPLC
Reference
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