Safety testing and characterization of Chinese hamster ovary cell bank.
Conducted safety and characterization analysis tests on over 200 Chinese hamster ovary (CHO) cell bank samples.
CHO cells are the most widely used production cell lines in the pharmaceutical industry, and their safety profile has been established for over 20 years. Guidelines for the safety and characterization analysis of CHO production cell lines are harmonized with the International Conference on Harmonisation (ICH) Q5 (R1) "Virus Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin" and ICH Q5D "Derivation, Characterization, and Production of Cell Lines for the Manufacture of Biological Products (Biotechnology-derived Products | Biologically-derived Products)." Since 2007, Sartorius has conducted safety and characterization testing for over 200 Chinese Hamster Ovary (CHO) cell bank samples. Our researchers possess extensive knowledge and experience and will provide advice on optimal and cost-effective testing strategies that comply with chemical and regulatory requirements. We will also consider the history of the cell lines and raw materials used during bank manufacturing when proposing test packages.
- 企業：Sartorius Stedim Japan K.K.
- 価格：Other
