[Sending recorded video] Cellca Cell Line Development Technical Update: 9 weeks until RCB

ザルトリウス・ステディム・ジャパン

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.

Date and time Thursday, Apr 06, 2023
03:00 PM ～
Capital
Entry fee Free

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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.

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
Manufacturing and Characterization of Cell Bank
Next-generation GMP cell banking

Zaltrius offers Cellca cell line development services. This platform enables the supply of consistently stable clones with a titer of 8 g/L in a fed-batch process within 14 weeks, without the need for optimization of yields in individual cases, from DNA to research cell bank (RCB). By combining GMP banking services and testing services, we mitigate risks and reduce time, completing the process from DNA to MCB manufacturing in 10 months.
Evaluation of physicochemical and biological equivalence of biosimilars.
Comprehensively supporting the early development of biopharmaceuticals on an independent platform.

**Experience and Achievements** Sartorius supports the evaluation tests of various biosimilar monoclonal antibodies, including the following, through a wide range of methods. Sartorius is with its customers throughout the development of biosimilars. A team of experienced scientists develops characterization methods for molecules that comply with regulatory requirements. This enables comprehensive evaluation of biosimilars against reference products.
Safety testing for biological products and viral vaccines.
Introducing comprehensive solutions for safety testing of biological products and viral vaccines.

Our company has developed and validated various assays for the characterization of cell banks derived from various species, including mice, hamsters, humans, and primates, and has experience with the following products: ▪ Biosimilar monoclonal antibodies ▪ Monoclonal antibodies ▪ Recombinant proteins ▪ Vaccines ▪ Gene therapy vectors ▪ Regenerative medicine products
New Biopharmaceutical Characterization Service
Integrated services with expertise and industry leadership.

【Expertise】 ▪ Over 10 years of experience ▪ 99% on-time delivery rate ▪ Scientists with extensive experience and knowledge ▪ Expertise in the development, optimization, and validation of complex potency bioassays and binding assays using cells ▪ Extensive established assays for routine characterization of monoclonal antibodies ▪ Specialized team of protein characterization experts
Cell line development and upstream process services
Using Cellca cell line development, over 120 projects have been successfully completed.

【Main Elements】 ▪ Cell lines & tests ▪ 4Cell CHO medium system ▪ Expression vector ▪ Upstream process