Sartorius Stedim Japan K.K. Official site

This webinar will focus on perfusion culture, which is gaining attention for process enhancement, and will introduce examples of utilizing Sartorius solutions. The bioreactors Ambr 15, Ambr 250 HT, and Biostat STR are compatible with perfusion culture. This time, we will explain the mechanisms and operational methods using Ambr 15 and Ambr 250 HT. Additionally, our CHO cell line development service utilizes the 4Cell SmartCHO medium, which can accommodate both fed-batch and perfusion cultures, and can also be used for suitable clone selection. Through examples that combine Ambr 15 and Ambr 250 HT with the same medium, we will convey the image of its application in process development. 【Seminar Overview】 ▪ Date: July 16 (Thursday) from 15:00 (approximately 30 minutes) ▪ Format: Webinar recorded broadcast [Japanese, Free] If you are unable to participate on the day, please register first. We will send you a URL for viewing later. *We kindly ask that participants refrain from registering with email addresses other than those from your own company or organization. Thank you for your understanding.

In this webinar, we will introduce the importance of real-time multivariate analysis and its implementation methods against the backdrop of advancements in digitalization in biopharmaceutical manufacturing. As a means to achieve continuous process monitoring required by ICH Q9/Q10, we will discuss MSPC using SIMCA-online, explaining three functions: anomaly detection based on golden batches, future predictions, and optimal operation proposals. Furthermore, through case studies of SIMCA-online implementation in cell culture, purification, and formulation processes, we will demonstrate specific values such as yield improvement, loss avoidance, and accelerated decision-making. Finally, we will touch on the processes and organizational requirements from PoC to full-scale implementation, summarizing practical points for transitioning to data-driven manufacturing. 【Seminar Schedule】 ▪ Date: July 30 (Thursday) from 15:00 (approximately 30 minutes) ▪ Method: Webinar recorded broadcast [Japanese, Free] If you are unable to participate on the day, please register first. A viewing URL will be sent to you later. *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.

We will explain the considerations for selecting the optimal filter, including the characteristics of membrane materials and structures, international and domestic regulations, and methods for estimating membrane area through small-scale tests. We will introduce key points for designing efficient and reliable filtration processes. 【Main Learning Content】 ■ Understanding the differences in filter materials and structures, and the selection points suitable for the process ■ Specific learning of methods for calculating membrane area using small-scale tests ■ Key points for filter selection and documentation in accordance with international and domestic regulations 【Seminar Overview】 ▪ Date: February 27 (Friday) from 3 PM (approximately 30 minutes) ▪ Method: Webinar recorded broadcast [Japanese, Free] *We apologize, but participation from individuals not affiliated with the same industry or using email addresses other than those of your organization is not permitted. Thank you for your understanding.

"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

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