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Page 26 of 26 June 2019 BioPharm International eBook 27 Single-Use Systems Commercial Bioreactors line, which also consists of 50-L, 200- L, 500-L, and 1000-L volumes, says Sébastien Chaussin, product manager of STR Bags, Sartorius Stedim Biotech. "The product is part of the compa- ny's bioreactor portfolio, which has proven scalability and geometric similarity from a volume of 100 mL in the ambr and up to 2000 L in the STR, and can support process devel- opment to commercial manufactur- ing," Chaussin states. The bioreactor portfolio provides a complete range of scalable, single- use upstream solutions covering cell- line selection, process development, seed train, and commercial manu- facturing as well as addressing latest industry trends such as process inten- sification and perfusion. The 2000-L bioreactor is suitable for intensified and perfusion processes benefiting from efficient oxygen transfer, mix- ing, and CO 2 stripping. The bioreactor is fully validated and qualified and is suited for com- mercial GMP manufacturing for the following cell types and applica- tions: mammalian, insect, stem cell culture, high cell density cultures exceeding 150 million cells /mL, adherent cell culture on microcarri- ers, and low-to-medium cell density microbial culture. The system features a magnetically driven shaft comprising two impel- lers that can be configured with two marine impellers (each with three blades), one marine impeller (with three blades), and one Rushton impeller (with six blades). A machine footprint of 10m²/107,6 ft² includes the control tower, bag holder, and platform. "Biostat STR 2000 L has a top drive motor for a classic stirred tank design, which is closely comparable to a stainless-steel bioreactor. A state- of-the-art double impeller stirring concept that can support high cell density cultures allows for high-level mixing performance and fluid flow dynamics," says Melisa Carpio, global technology consultant, Sartorius Stedim Biotech. The bioreactor bag is made of Flexsafe film, and SSB has con- trol over the bag production pro- cess, from the resin to the final sterilized bag, enabling consistent lot-to-lot cell growth performance. A distributed control system for stan- dard instruments is used and an alternative, industrial PLC control- ler is offered for customized projects. Meanwhile, large doors provide easy access for safe bag installation and a lifting device can be used to assist in bag handling. The ease-of-use concept enables fast and straightforward instal- lation. The working volume range of the STR 2000 is 500 L to 2000 L. Due to the fully rounded bag design with no straight corners, the entire working volume is mixed in an optimal time- frame with no dead zones. In addition, the system controls can be programmed to adapt the optimal gassing and stirring strate- gies depending on the volume. The drain-line positioning at the bottom of the vessel allows for complete har- vesting of the bag contents with min- imal loss of product. Standard hardware components include: • Intuitive local controller with full connectivity • Wide ra nge of pro cess a na- ly tical technolog y (PAT ) sin- gle-use a nd mult i-use sensor technology available • Advanced aeration concept to attain high oxygen transfer rates and remove excessive CO 2 using a stripping gas flow • Double wall for optimal culture heating and cooling • Up to six built-in pumps easily accessible at control tower front • Up to six configurable mass flow controllers (MFCs) • Built-in ladder and platform for easy access to connections located at the top of the bioreactor. Optional hardware/controller com- ponents include: • Programmable logic controller (PLC)-based customized controller • Connectivity to third-party distrib- uted control system controller (e.g., Delta V) • Connectivity to supervisory con- trol and data acquisition systems (including SSB-owned MFCs) • On-demand pump and MFC con- figuration • Bag testing at point-of-use Optional consumable components include: • Capacitance-based viable biomass with BioPAT Viamass • Configurable tubing lines to adapt to any customer need, includ- ing connectivity to cell retention devices (e.g., alternating tangential flow filtration) • Connectivity for multi-use sensors, such as trace for low-glucose process control • X-gas for process control based on exhaust gas composition. BP Ad Index Company Page CATALENT 21 DISTEK INC 9 SARTORIUS STEDIM BIOTECH 5 SINGLE USE SUPPORT GMBH 15 WUXI BIOLOGICS U 2

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