Cytiva

検索のヘルプ

Location:Homeテクニカル情報配信サービスPharma Mail

参考文献

  1. はじめに
  2. クロマトグラフィー精製の利点
  3. 血漿供給
  4. 第VIII因子製剤
  5. アルブミン製剤
  6. IgG製剤
  7. 第VIII因子の精製プロセス
  8. アルブミンの精製プロセス
  9. IgGの精製プロセス
  10. 生物学的安全性
  11. 製造プラントのプランニングとエンジニアリング
  12. チェックリスト
  13. 参考文献(当ページです)
  14. 精製プロセスの概要

  1. Note for guidance on minimizing the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMEA/410/01 Rev. 2 -October 2003). Official Journal of the European Union. 2004, C 24/03.
  2. Johnston, A. et al. Inactivation and clearance of viruses during the manufacture of high purity factor VIII. Biologicals 28 129-136 (2000).
  3. Lebing, W.R. et al. Development and scale up of a production-scale chromatographic process for the production of human IgG. Downstream 31 p.19 (2000).
  4. Cameron, R. et al. The removal of model viruses, poliovirus type 1 and canine parovirus, during the purification of human albumin using ion-exchange chromatographic procedures. Biologicals 25 391-401 (1997).
  5. Davies, J.R. et al. Large scale manufacture and properties of chromatographically purified albumin for therapeutic use. Australasian Biotechnology March/April (1996).
  6. Wolf, M. et al. A safety study of Albumex™R 5, a human albumin solution produced by ion exchange chromatography. Vox. Sang. 70 198-202 (1996).
  7. Berglof, J.H. Validation aspects relating to the use of chromatographic media, in Biotechnology of Blood Proteins (Rivat, C. and Stoltz, J-F., eds) Colloque INSERM/John Libbey Eurotext Ltd. Vol. 227 p. 31-36 (1993).
  8. Shuliang, Z. et al. Application of chromatography system in plasma protein fractionation on pilot scale, in Biotechnology of Blood Proteins (Rivat, C. and Stoltz, J-F., eds) Colloque INSERM/John Libbey Eurotext Ltd. Vol. 227 p.137-142 (1992).
  9. Yap, H.B. et al. Development of a process for the preparation of human serum albumin using chromatographic methods in Biotechnology of Blood Proteins (Rivat, C. and Stoltz, J-F., eds) Colloque INSERM/John Libbey Eurotext Ltd. Vol. 227 p.143-149 (1993).
  10. S.B. Marrs. Large scale albumin fractionation by chromatography, in in Biotechnology of Blood Proteins (Rivat, C. and Stoltz, J-F., eds) Colloque INSERM/John Libbey Eurotext Ltd. Vol. 227 p.169-174 (1992).
  11. Burnouf, T. Integration of chromatography with traditional plasma protein fractionation methods. Bioseparation 1(5-6) 383-396 (1991).
  12. Berglof, J.H. Eriksson, Andersson, I. New supports for plasma protein fractionation. Optimization and application of gel filtration using an improved Sephacryl™ S-200 gel. Develop. Biol. Standard. 67 25-29 (1987).
  13. Berglof, J.H., Eriksson, S., Curling, J. Chromatographic preparation and in vitro properties of albumin from human plasma. J. Appl. Biochem. 5 282-292 (1983).
  14. Curling, J. et al. A chromatographic procedure for the purification of human plasma albumin. Vox. Sang. 33 97-10 (1977).

次へ(精製プロセスの概要)


お問合せフォーム

※日本ポールの他事業部取扱い製品(例: 食品・飲料、半導体、化学/石油/ガス )はこちらより各事業部へお問い合わせください。