Sartorius Stedim Japan K.K. Product Lineup

Process Intensification (PI) is a comprehensive framework aimed at maximizing overall production volume across manufacturing units, manufacturing processes, or biopharmaceutical facilities. Sartorius Stedim offers scalable and versatile modular solutions, including high-throughput process development tools. These can be implemented in current and future manufacturing facilities for a variety of upstream and downstream PI scenarios. - Enables faster drug development - Improves efficiency and productivity in GMP manufacturing - Applicable to various processes regardless of the pharmaceutical ◆ International Webinar [Process Intensification Webinar Series] This webinar series provides a comprehensive guide to maximizing process intensification. It covers upstream and downstream strategies, media management, data analysis, and more. You can watch it here: ⇒ https://bit.ly/3ihwdT1

Overview of SIMCA-Online ▪ Remote prediction monitoring ▪ Root cause analysis ▪ Prediction of final quality characteristics ▪ Soft sensing ▪ Real-time monitoring and control

SIMCA enables the integration and analysis of diverse data sources, helping to identify and understand hidden data that holds the key to business success, and supports decision-making based on that understanding. 【Areas of SIMCA】 SIMCA can be utilized in any environment where data is generated, contributing to the growth of businesses across various industries. ▪ Bioprocess companies: Achieved a 75% improvement in process yield, a 40% reduction in cycle time, and tripled plant productivity. ▪ Global food processing companies: Solved logistics challenges, reducing transportation costs by $1 million annually. ▪ Wastewater treatment companies: Achieved a cleaner and safer environment through process improvements.

The introduction of superior Design of Experiments (DOE) solutions enables further reduction in product time-to-market. MODDE, the innovative DOE solution from Sartorius Stedim Data Analytics, supports the interpretation of results through its user-friendly graphic interface and data analysis assistance features. **Features of MODDE** MODDE is a solution that goes beyond mere DOE software. It provides high-quality analyses for decision-making while monitoring risks by alerting to critical settings, leading to more robust conclusions. - Reduction in the number of required experiments - Guidance features for experimental design - Reliable data handling - Support for better decision-making - Integration with existing systems - Achievement of quality goals

BioPAT(R) Spectro is a product specifically developed for Quality by Design (QbD). By generating more process data using this product, the potential of Raman spectroscopy can be maximized. This enables the construction of very robust processes, resulting in the production of consistently high-quality products.

■ Focus on important matters ■ Quick overview ■ Process safety ■ Advanced charting ■ Calculation functions ■ Complete process control ■ Data integrity and security ■ Regulatory compliance

【Advantages】 ▪ Real-time online monitoring of bioprocess parameters ▪ Glucose and lactic acid ▪ Methanol or ethanol ▪ Enabling automatic parameter supply | Air intake control capability ▪ Compact space-saving design ▪ Biosensors provide stable performance at room temperature ▪ Linearity over a wide measurement range

One of the most essential parameters for customers in the cell culture process is biomass (live cell count). Understanding the fluctuations in live cell count during the culture process leads to deeper insights and understanding of the process. This allows for the control of feed, harvest, and infection timing in accordance with these fluctuations. BioPAT Viamass is fully integrated into standard culture control systems and is the first standard online biomass measurement solution for single-use culture systems, compatible with single-use culture bags such as Flexsafe RM.

This application note included in the eBook demonstrates how to gain process insights using screening ensembles. By applying the insights obtained, it enables process optimization without compromising cell quality. 1. Design of multifactor experiments 2. Validation of high-performance media and reagents 3. Characterization analysis of target cells 4. Data analysis for practical insights 5. Utilization of screening platforms for continuous iteration

Selecting the appropriate combination of culture media and feeds for cells, and further optimizing process parameters, is a complex and time-consuming process. Sartorius's extensive portfolio of media and micro-bioreactors that allow for parallel cultivation support optimal and scalable process development for cells. This application note introduces the process optimization of CHO cell culture using Sartorius media, Ambr15, and the experimental design software MODDE.

Biobrain Supervise enables the incorporation of new standards in biopharmaceutical manufacturing process data management and automation. Whether it is a single-use system or a multi-use system, Biobrain Supervise is the optimal tool for any upstream and downstream processes, providing reliable data collection, efficient trend monitoring, and advanced recipe control.

【Features and Benefits】 ■ Compliant with current GMP (applicable for standalone operation and various embedded configurations) ■ Adheres to industry standard specifications (GAMP 5 Category 4, ISA-88, etc.) ■ Extensive customization options ■ Reduces training burden ■ Continuously enhances functionality, security, and types of compatible devices