生物技术产品质量：用于生产生物技术/生物制品的细胞基质的来源与特性。国际协调会议三方协调指南。 - Suppr

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超能文献

Quality of biotechnological products: derivation and characterisation of cell substrates used for production of biotechnological/biological products. ICH Harmonised Tripartite Guideline.

出版信息

Dev Biol Stand. 1998;93:223-34.

PMID:9737399

Abstract

摘要

相似文献

Quality of biotechnological products: derivation and characterisation of cell substrates used for production of biotechnological/biological products. ICH Harmonised Tripartite Guideline.生物技术产品质量：用于生产生物技术/生物制品的细胞基质的来源与特性。国际协调会议三方协调指南。

Dev Biol Stand. 1998;93:223-34.

Quality of biotechnological products: analysis of the expression construct in cell lines used for production of r-DNA derived protein products. ICH Harmonised Tripartite Guideline.生物技术产品质量：用于生产重组DNA衍生蛋白产品的细胞系中表达构建体的分析。国际人用药品注册技术协调会三方协调指导原则

Dev Biol Stand. 1998;93:205-8.

Quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. ICH Harmonised Tripartite Guideline.生物技术产品的质量：源自人或动物细胞系的生物技术产品的病毒安全性评估。国际协调会议三方协调指南。

Dev Biol Stand. 1998;93:177-201.

Quality of biotechnological products: stability testing of biotechnological/biological products. Annex to the ICH Harmonised Tripartite Guideline for the Stability Testing of New Drug Substances and Products.生物技术产品的质量：生物技术/生物制品的稳定性试验。国际人用药品注册技术协调会《新药原料药和制剂稳定性试验指导原则》三方协调指南附件

Dev Biol Stand. 1998;93:211-9.

International Conference on Harmonisation; guidance on quality of biotechnological/biological products: derivation and characterization of cell substrates used for production of biotechnological/biological products; availability. Notice. Food and Drug Administration, HHS.国际协调会议；生物技术/生物制品质量指南：用于生产生物技术/生物制品的细胞基质的来源与特性；可获取性。通知。美国卫生与公众服务部食品药品监督管理局

Fed Regist. 1998 Sep 21;63(182):50244-9.

WHO requirements for the use of animal cells as in vitro substrates for the production of biologicals (requirements for biological substances No 50).世界卫生组织关于使用动物细胞作为生物制品生产的体外基质的要求（生物制品要求第50号）。

Dev Biol Stand. 1998;93:141-71.

ICH guidelines and PhEur monographs on derivation and characterisation of cell substrates used for production of biotechnological/biological products. International Conference on Harmonisation.用于生物技术/生物制品生产的细胞基质的来源和特性鉴定的国际协调会议（ICH）指南及欧洲药典专论。国际协调会议。

Dev Biol Stand. 1999;98:159-65; discussion 167.

Current good tissue practice for human cell, tissue, and cellular and tissue-based product establishments; inspection and enforcement. Final rule.人类细胞、组织以及基于细胞和组织的产品生产机构的现行良好组织规范；检查与执法。最终规则。

Fed Regist. 2004 Nov 24;69(226):68611-88.

WHO requirements for the use of animal cells as in vitro substrates for the production of biologicals: application to influenza vaccine production.世界卫生组织关于使用动物细胞作为生物制品生产体外基质的要求：在流感疫苗生产中的应用

Dev Biol Stand. 1999;98:153-7; discussion 167.

Quality control of bovine serum used for vaccine production.

Dev Biol Stand. 1999;99:61-8.

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