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.
basic information
You can check the following contents from this catalog: ▪ Safety tests and characterization analysis of Chinese Hamster Ovary (CHO) cell bank ▪ Master Cell Bank (MCB) testing and End of Production Cell Bank (EoPC) testing ▪ Working Cell Bank (WCB) testing ▪ Genetic characteristic assays ▪ Provision of integrated services ▪ Technical notes
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Applications/Examples of results
For more details, please refer to the PDF document or feel free to contact us.
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[Sending recorded video] Cellca Cell Line Development Technical Update: 9 weeks until RCB
Registration for this webinar has ended. If you wish to view it, please contact us. We will send you the URL for the recorded video at a later date. At Sartorius, we have been providing CHO cell line development services that serve as the foundation for the manufacturing of antibody and protein therapeutics. Two products developed through this service have already been launched, and over 40 molecules are currently in clinical development. This webinar will be divided into two parts to introduce this service. In Part 1, we will present the technical upgrades of this service. In Part 2, we will introduce the media products and related services that have been optimized for this service and are now available for general sale. [Seminar Overview] April 6, 2023 (Thursday) 15:00 (approximately 50 minutes) Webinar recorded broadcast [Japanese, free] *We sincerely apologize, but participation from companies in the same industry and email addresses other than those of your organization is not permitted. Thank you for your understanding.
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[Sending Recorded Video] Services Offered by Sartorius - Introduction to Cell Line Development, Cell Banking, and Various Tests.
Participation in this webinar has ended. If you wish to view it, please contact us. We will send you the URL for the recorded video at a later date. There is a growing need to obtain CHO cell lines with high expression levels in as short a time as possible for the development and manufacturing of protein drugs such as antibody therapeutics. Sartorius' Cellca cell line development service has developed over 140 CHO cell lines to date, which are used for commercial or clinical trial manufacturing. In this webinar, we will introduce the technical background, service formats (contract and licensing), as well as the characterization tests and safety tests for antibody drugs, protein drugs, and various cells (gene and cell therapy, vaccines, etc.). *We sincerely apologize, but participation from email addresses other than those of your company or organization is not permitted. Thank you for your understanding.
