参考文献
- はじめに
- クロマトグラフィー精製の利点
- 血漿供給
- 第VIII因子製剤
- アルブミン製剤
- IgG製剤
- 第VIII因子の精製プロセス
- アルブミンの精製プロセス
- IgGの精製プロセス
- 生物学的安全性
- 製造プラントのプランニングとエンジニアリング
- チェックリスト
- 参考文献(当ページです)
- 精製プロセスの概要
- 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.
- Johnston, A. et al. Inactivation and clearance of viruses during the manufacture of high purity factor VIII. Biologicals 28 129-136 (2000).
- 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).
- 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).
- Davies, J.R. et al. Large scale manufacture and properties of chromatographically purified albumin for therapeutic use. Australasian Biotechnology March/April (1996).
- 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).
- 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).
- 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).
- 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).
- 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).
- Burnouf, T. Integration of chromatography with traditional plasma protein fractionation methods. Bioseparation 1(5-6) 383-396 (1991).
- 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).
- 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).
- 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)
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