Safety of biological products prepared from mammalian cell culture : conference centre of the Marcel-Mérieux Foundation. Les Pensières, Veyrier-du-Lac, Annecy, France, September 29-October 1, 1996 /
| Other Authors: | |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
Basel ; New York :
Karger,
1998.
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| Series: | Developments in biological standardization ;
93. |
| Subjects: |
Table of Contents:
- Historical background, objectives and overview-- Karyology and tumorigenicity testing requirements; past, present and future-- Cell line banking and authentication-- Raw materials as a source of contamination in large-scale cell culture-- Zoonoses and haemorrhagic fever-- Overview of biological effects of addition of DNA molecules to cells-- Risk potential of the chromosomal insertion of foreign DNA-- DNA issues-- Residual host cell protein from continuous cell lines. Effect on the safety of protein pharmaceuticals-- An overview of the BSE epidemic in the UK
- Transmission of spongiform encephalopathy through biological products-- New variant Creutzfeldt-Jakob disease-- Problems with BHK 21 cells-- Experiences of virus, retrovirus and retrovirus-like particles in Chinese Hamster Ovary (CHO) and Hybridoma Cells used for production of protein therapeutics-- Human diploid cell strains (HDCS) viral vaccines-- Chromosomal characterization of MRC-5 cell banks utilizing G-banding technique-- Experience with the vero cell line-- DNA in plasma of human blood for transfusion-- Discussions
- WHO requirements for the use of animal cells as in vitro substrates for the production of biologicals-- International conference on harmonisation (ICH)-- Quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin-- Quality of biotechnological products: analysis of the expression construct in cell lines used for production of r-DNA derived protein products
- Quality of biotechnological products: stability testing of biotechnological/biological products-- Quality of biotechnological products: derivation and characterisation of cell substrates used for production of biotechnological/biological products