Sartorius Stedim Japan K.K. List of News Articles

In this exhibition booth, we will introduce the latest solutions to make the final filling process safer and more reliable. The new product Sartopore Evo, launched this year, is a "next-generation filter" designed for the final filtration sterilization process, balancing reduced adsorbent interaction and high flow rates while also considering the increasingly important PFAS compliance. We invite you to experience the evolution of membrane technology that Sartorius has developed over more than 100 years at the venue. Seminar Points: - Introduction of Sartorius' latest filter products and integrity testing equipment that support pharmaceutical manufacturing - Evolution of filter technology from the Sartobran of the 1970s to the latest Sartopore Evo - Integrity testing equipment Sartocheck 5, which fully meets data integrity requirements - Internal cleaning service for integrity testing equipment scheduled to start this winter We hope to provide valuable information for everyone involved in the final filling process, which serves as the last bridge to patients. Date: December 2nd and 3rd (Lunch seminar on the 3rd from 11:50 to 12:50) Venue: Tower Hall Funabori

"Next-Generation CHO Cell Line Development Service Integrating AI and Process Intensification - Innovation of Sartorius CLD Workflow" In biopharmaceutical development, establishing high-quality cell lines in a short period has become increasingly important. Sartorius's Cell Line Development (CLD) service has supported the approval of 7 antibody products and over 80 clinical projects to date. Seminar Points: ■ The latest workflow that selects optimal clones by AI analysis of nano-well images and fluorescence data immediately after single-cell cloning with CellCelector ■ A series of CLD processes that continue from Clone Evaluation, quality analysis, scale-up, to technology transfer to CDMO ■ Process Intensification strategies based on High Inoculation Fed-Batch and Perfusion culture ■ Media optimization service that can be used independently (supporting non-GMP prototypes to GMP manufacturing scale) Date and Time: December 3 (Wednesday) 12:20–13:20 Venue: Omiya Sonic City, Exhibition Hall 2

The final filtration sterilization process in biopharmaceutical manufacturing is a critical process that requires ensuring the efficacy of the product while guaranteeing safety. The PVDF filters commonly used in this process have excellent low adsorption properties, but they contain PFAS, which raises concerns about their impact on the environment and health. Sartorius has addressed this challenge by developing a new filter made from PES material that intentionally does not use PFAS, called "Sartopore Evo." This product significantly reduces protein adsorption compared to conventional PES filters due to its innovative surface treatment technology, achieving low adsorption properties comparable to PVDF filters. Additionally, the excellent liquid flow characteristics of the PES material enable high-flow filtration, contributing to the efficiency of the final filtration sterilization process. In this webinar, we will provide a detailed introduction to the performance and benefits of the new PES filter "Sartopore Evo." 【Seminar Overview】 ▪ Date: November 27 (Thursday) at 3:00 PM (approximately 30 minutes) ▪ Method: Webinar recorded broadcast [Japanese, free of charge] *We 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.

The Ambr 250 High Throughput is a high-throughput bioreactor that accelerates process development and process characterization analysis. It enables simultaneous cultivation of up to 24 samples while incorporating automated control via a robotic arm and integration with external analytical devices. The culture containers are single-use specifications of 100-250 mL and are compatible with perfusion culture and microcarrier culture. This device has been enhanced based on customer feedback and was launched as the second generation, Ambr 250 High Throughput Generation 2, starting in 2025 to demonstrate further performance as a scale-down model. In this webinar, we will introduce the device overview and the enhanced features in Generation 2. 【Seminar Overview】 ▪ Date: October 16 (Thursday) at 15:00 (approximately 30 minutes) ▪ Method: Webinar recorded broadcast [Japanese, Free] *We 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.

In this webinar, we will introduce Sartorius's innovative virus quantification device, Virus Counter Plus. Virus Counter Plus employs flow cytometry technology that allows for the direct measurement of virus particle counts in just a few hours, compared to traditional plaque assays and qPCR, enabling rapid virus quantification. The only work required for measurement is mixing the sample with the reagent, eliminating the need for skilled techniques. This prevents the task from becoming dependent on specific individuals and significantly reduces training burdens. Additionally, it is equipped with an auto-sampler, achieving high-throughput measurements. By setting up dozens of samples before leaving work, automatic analysis can proceed overnight, allowing results to be checked the following morning. This accelerates development speed, enables real-time monitoring of processes, and facilitates quick decision-making during manufacturing. 【Seminar Overview】 ▪ Date: October 16 (Thursday) from 3 PM (approximately 30 minutes) ▪ Method: Webinar recorded broadcast [Japanese, free of charge] *We apologize, but participation from companies in the same industry and email addresses other than those from your organization is not permitted. Thank you for your understanding.

We will be exhibiting and presenting a luncheon seminar at BioJapan 2025, which will be held at Pacifico Yokohama from October 8 to 10, 2025. At our booth, we will introduce our cell line development services and media optimization services that achieve a scalable fed-batch process with a monoclonal antibody titer of up to 10 g/L in just 9 weeks, from DNA to RCB. We will also showcase single-use culture vessels for process development. In addition, during the luncheon seminar, we will provide a clear overview of Sartorius' CLD services, making it easy to understand for those who are new to the topic. If you are considering shortening timelines, optimizing product quality, or exploring flexible development strategies, please join us. We look forward to seeing you there. Event Overview: October 8 (Wed) - 10 (Fri), 2025, Pacifico Yokohama Exhibition Booth: Small Booth Number D-109 Luncheon Seminar: Title: Minimizing Risks in CHO Cell Line Development through Automation and Predictive Models Seminar Date and Time: October 9 (Thu) 11:30 AM - 12:30 PM

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. Sartorius has developed CHO cell lines for over 300 projects, with 7 projects approved and more than 80 in clinical trials. The projects include IgG1, 2, 4, multi-specific antibodies, Fc fusion proteins, enzymes, hormones, new drugs, and biosimilars. Our customers range from large companies to startups, with over 70% of them being repeat clients. In this webinar, we will introduce the details of our flexible and comprehensive services, including CHO cell line development, MCB/WCB manufacturing and testing, molecular characterization, FUT8 Knock Out, provision of optimized media, and process enhancement. *We sincerely apologize, but we kindly ask that participants refrain from joining with email addresses other than those from your company or organization. Thank you for your understanding.

We will be exhibiting and presenting a seminar at TIDES Asia 2025, which will be held in Kyoto from February 26 to 28, 2025. TIDES Asia is the leading conference in Asia that gathers experts in oligonucleotides, peptides, mRNA, and genome editing therapeutics. At this conference, we plan to showcase high-throughput TFF equipment for parallel screening and hold a seminar on innovative solutions for peptide therapeutic manufacturing. We look forward to your visit. 【Event Overview】 Date: February 26 (Wednesday) - 27 (Friday), 2025 Location: The Westin Miyako Hotel Kyoto *Pre-registration required 【Our Seminar】 Title: Fit for Future: Advancing Bioprocess Manufacturing by Identifying Top Performing Clones and Enhancing Productivity through Process Intensification Seminar Date and Time: 27th (Thursday) at 15:45

To maximize the performance of CHO cells, it is necessary to select the optimal medium for each clone and further optimize the process parameters. Sartorius offers a variety of basic media and feeds suitable for Fed-batch culture of major CHO cell lines such as CHO-DG44, K1, S, and GS. In this webinar, we will introduce a case study that combines these CHO media, the automated microbioreactor Ambr15, and the experimental design software MODDE to conduct medium screening and process optimization in a short period. We will also provide information about our Benchmark Study service, which allows you to outsource the selection of the optimal medium and process development for your specific cell line to our research institute in Germany. 【Seminar Overview】 ▪ Date: March 6, 2025 (Thursday) from 3:00 PM (approximately 40 minutes) ▪ Method: Webinar recorded broadcast [Japanese, Free] If you are unable to participate on the day, please register first. We will send you a viewing URL later. *We kindly ask that participants from other companies in the same industry, as well as those using email addresses not affiliated with your organization, refrain from joining. Thank you for your understanding.

In the pharmaceutical and biopharmaceutical industry, there is an increasing need to maintain world-class quality and adopt the latest technologies to enhance technical skills and productivity. The biggest challenge faced is responding to new compliance measures and regulations. At Sartorius, we have prepared training courses focused on practical exercises, aimed at enabling our customers to perform their work safely and efficiently. The courses listed can also be customized to meet your specific needs. If necessary, they can be held remotely. You can apply using the "Dedicated Form" on page 11 of the "Related Materials" or through the "Related Links." You can check the schedule from the "Related Materials." We look forward to your participation in Sartorius training.