Sartorius Stedim Japan K.K. List of Products and Services

The "Ambr15 Generation2" is a high-throughput automated micro-scale bioreactor system that replicates the performance of laboratory-scale bioreactors. The system consists of single-use vessels, an automated workstation, and user-friendly software. It is designed to be installed in standard biosafety cabinets for aseptic operations, allowing for parallel monitoring and control of 24 or 48 micro-bioreactor cultures. 【Features】 ■ Reduces operator time and increases work efficiency ■ Facilitates the process of determining the best clone ■ Enables faster and more accurate operations ■ Capable of complex liquid mixing and addition for multifactorial experimental designs (DoE) ■ Used in research facilities worldwide *For more details, please refer to the PDF document or feel free to contact us.

The Ambr1515 Generation 2 is a high-throughput "automated micro-scale bioreactor system" that reproduces the performance of laboratory-scale bioreactors. The system consists of single-use vessels, an automated workstation, and enhanced convenience software. It is designed to be installed in a standard biosafety cabinet for aseptic operations, allowing for parallel monitoring and control of 24 or 48 micro-bioreactor cultures. As the manufacturing processes for biopharmaceuticals become more complex and the density of cultures increases, scientists around the world are facing an unprecedented challenge in developing "clone, medium, and process" that meet new demands. The Ambr15 Generation 2 system enhances equipment performance that influences the success of cultures, improves flexibility, and incorporates new features that reflect user feedback. It helps address the aforementioned challenges and supports the acceleration of research by scientists.

You can find the following information in this catalog: ▪ System specifications ▪ Compatible at-line analyzers ▪ Expandable options ▪ Accessories ▪ Ambr 15 microbioreactor (culture vessel) ▪ Plates and chips

The "Ambr250" is a new bioreactor system for parallel operations of microbial or cell cultures using single-use bioreactors with a capacity of 100 to 250 mL, controlled by an automated liquid handling platform. This system was developed in collaboration with two major pharmaceutical companies, based on the micro bioreactor technology held by Sartorius Stedim's TAP division. It supports the necessary culture conditions required for microbial cultivation and mammalian cell culture, which demand advanced technology, as well as applications that require larger sample collections. 【Features】 ■ Individual control of all process parameters ■ Improved operating environment ■ Efficient and rapid miniaturization system ■ Equipped for scalability to benchtop bioreactors ■ Capable of screening a wide range of culture conditions and strains or cell lines *For more details, please refer to the PDF document or feel free to contact us.

The "Ambr250 Perfusion" is a fully automated multi-parallel bioreactor system that uses single-use culture vessels of 100-250 mL to accelerate the development of scalable perfusion processes. This system allows for the simultaneous execution of up to 24 different perfusion cultures while returning cells to the culture vessel using hollow fibers, which are commonly reported specifications. This system transforms the perfusion processes that could not be achieved with multi-parallel or small-scale setups, reducing experimental costs with small volumes and accelerating the optimization of high-density cell culture processes. 【Features】 ■ Increased productivity / Reduced experimental costs ■ Simultaneous parallel fed-batch and perfusion cultures are also possible ■ Exceptional scalability ■ Sampling and reagent addition are performed by a fully automated liquid handler, reducing daily working hours *For more details, please refer to the PDF document or feel free to contact us.

The industry-standard multi-channel, compact fully automated bioreactor, Ambr250 in a benchtop configuration, has arrived with new features and applications for regenerative medicine. It allows for independent cultivation with highly controlled single-use containers with operating capacities of 100-250 mL, arranged in a maximum of 8 channels. There are three types of containers, each specialized for cells, microorganisms, and regenerative medicine, with a refined design that contributes to process development and optimization. Since the containers are single-use and sterilized, they enable fast turnover, accelerating customers' research and development activities. Because it is geometrically identical to bioreactors used for production scale in pharmaceuticals and regenerative medicine products, it is possible to quickly transition and implement optimized cultivation and production conditions.

The Ambr 250 High Throughput Generation 2 is a multi-parallel bioreactor system that accelerates process development and characterization analysis schedules to achieve cost reduction. Its fully continuous gas supply system realizes similarity with large-scale bioreactors and optimizes the scale-down model. Through the integration of analysis options such as the capacitance-based BioPAT Viamass, it supports extensive feedback control.

Biostat RM has been renewed with a new control tower that adopts the automation platform Biobrain, which is suitable for commercial production using a shaking-type bioreactor. 【Features】 ▪ Accelerates the market launch of customer products ▪ Simple transition from process development to commercial production ▪ Flexible specifications for diverse manufacturing needs and culture styles ▪ High-precision process control ▪ Support system by technical personnel stationed in various countries

- The BioStat RM is a single-use rocking bioreactor that is fully compliant with GMP. < BioStat RM 20 | 50 Basic > The BioStat RM 20 | 50 Basic is a standalone bioreactor that is the ideal size for benchtop use. < BioStat RM 200 > The BioStat B and RM 200 Rocker are single-use rocking bioreactors designed for large-scale applications. - The Flexsafe bags have a proven track record with a wide range of cell lines including CHO, NS0, SF9, E. coli, T cells, and mesenchymal stem cells. Using Flexsafe RM bags in the seed train allows for easy scale-up to the BioStat STR single-use bioreactor that utilizes Flexsafe STR bags. The same polyethylene film material can be used for all cell culture steps. Flexsafe RM bags can be used with rocking bioreactors from multiple manufacturers, providing excellent growth characteristics and robustness, with stable supply.

Key Features: ▪ Supports consistent cell growth with the industry-leading Flexsafe RM TX film, known for its reliability ▪ Reduces contamination risk through a closed system ▪ Significantly improves cell recovery yield with a unique gravity harvest ▪ Achieves unmanned monitoring and control of cell culture, including online biomass measurement, through an advanced automation system ▪ Achieves optimal cell growth with a well-established rocking platform

The "Biostat STR Series" is a single-use bioreactor system designed for rapid process development and seamless scale-up to commercial production. The newly launched third generation features a new automation platform, "BIOBRAIN," and the analytical tool "BioPAT(R)," enabling exceptional speed, quality, and productivity. Stable and predictable processes greatly contribute to providing safe and reliable biopharmaceuticals to patients worldwide, accelerating our customers' manufacturing operations and business.

The Biostat B-DCU is a fermenter | bioreactor designed to meet various requirements for process optimization and characterization, particularly in the biotechnology and biopharmaceutical industries. It serves as an optimal scale-down model for large-scale production, offering advanced features and an unparalleled range of options for cell culture and microbial culture processes.

"Biostat B" is a benchtop bioreactor equipped with a control tower that possesses multi-talented capabilities to meet the diverse and varied needs of our customers. It offers a multitude of possibilities by combining three types of culture vessels with proven performance in single and twin configurations. With thousands of units delivered in over 50 countries worldwide, our extensive experience and collaboration with customers globally support this track record. [Features] ■ A bioreactor with proven performance worldwide ■ Custom-made devices can be produced to meet customer specifications using our unique design system ■ Established high quality *For more details, please refer to the PDF document or feel free to contact us.

One device for everything! Univessel Glass is our platform culture vessel that can be used with all Biostat benchtop bioreactors. You can choose from capacities of 1 L, 2 L, 5 L, and 10 L. Thanks to the new design and compatibility with the old version, any existing probes, dip tubes, spargers, or impellers can be adapted to fit this new Univessel Glass.

▪ Proven scalable design Reduction of time and effort for process development, optimization, and validation ▪ Compatibility with existing bioreactor controllers Making existing bioreactor controllers more user-friendly with single-use culture vessels employing cutting-edge technology ▪ Interchangeable with existing glass containers Facilitating peak usage relief and efficient schedule management ▪ Single-use from container to sensor Enabling more cultures with current equipment

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.

【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

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.

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

【Advantages】 ▪ Specifications designed to accommodate all microbial culture processes ▪ Production of plasmid DNA ▪ Microbial culture bags that have undergone qualification for GMP manufacturing ▪ Improved productivity and user-friendly ▪ Refined process control proven in cell culture

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.