Single-use bioreactor backbone, Sartorius Stedim BIOSTAT STR powers large-scale biologics

Sartorius Stedim’s BIOSTAT STR single-use bioreactor system has become a core workhorse for large-scale biologics and vaccine production, offering volumes up to 2,000 liters, integrated automation and compatibility with modern downstream processes.

Edited by ad hoc news Flagship & Bestseller Desk. Reviewed before publication on 06/15/2026 at 3:24 PM ET. Details in the imprint.

The BIOSTAT STR single-use bioreactor system from Sartorius Stedim Biotech has evolved into a central platform for large-scale biologics and vaccine manufacturing, with working volumes ranging from 50 liters up to 2,000 liters in a fully disposable bag format. The system is designed for upstream processing of monoclonal antibodies, recombinant proteins and cell therapies, combining pre-sterilized single-use bags with integrated sensors and closed fluid paths to reduce cleaning downtime and cross-contamination risk.

How BIOSTAT STR is built for large-scale single-use production

At the core of BIOSTAT STR is a family of stirred-tank bioreactors that use pre-assembled, gamma-irradiated Flexsafe STR bags, typically available in nominal volumes of 50, 200, 500, 1,000 and 2,000 liters, each with a 3-to-1 aspect ratio similar to stainless-steel vessels to support comparable mixing and mass transfer characteristics. The single-use bags integrate spargers, impellers, sampling ports and sterile connectors, allowing operators to perform inoculation, feeding, sampling and harvest through closed connections that are compatible with common aseptic welding and sealing technologies.

The reactor hardware uses a stainless-steel support housing with magnetically coupled, bottom-mounted impellers, eliminating shaft seals and reducing the risk of leaks while enabling gentle to vigorous agitation depending on the cell line and culture phase. Sartorius specifies that BIOSTAT STR is optimized for high cell density mammalian processes, with kLa and mixing time performance tuned through the combination of proprietary impeller designs and configurable sparger options, making it suitable for both fed-batch and perfusion modes. Inline single-use pH and dissolved oxygen sensors are embedded in the bags, and the system can be equipped with additional sensor ports for parameters such as viable cell density or glucose when supported by third-party analytics.

Automation is provided through the BIOSTAT STR control tower, which integrates process control, alarms and data acquisition, and can be combined with the company’s BioPAT toolbox for advanced process analytics and model-based control strategies. According to Sartorius, the control platform can link to higher-level manufacturing execution systems (MES) and distributed control systems (DCS) using standard industrial communication protocols, supporting 21 CFR Part 11 compliance for electronic records in regulated biologics production environments. The control software enables recipe management, automated feed profiles, cascade control of dissolved oxygen via gas blends and agitation, and automated process phase transitions between inoculation, growth and production stages.

The BIOSTAT STR platform has been positioned by Sartorius as part of a broader upstream ecosystem that includes media preparation systems, single-use mixing tanks and the Ambr high-throughput mini-bioreactor range, allowing process development at milliliter scale and linear scale-up to production volumes in the same bag family and control philosophy. For downstream connectivity, the design of the Flexsafe STR bags and tubing sets is aligned with Sartoflow single-use tangential flow filtration skids and Sartorius single-use chromatography solutions, enabling an end-to-end single-use bioprocess where intermediates are transferred through sterile, closed connections without exposing product streams to the environment.

Beyond hardware, BIOSTAT STR is supported by application consulting and process optimization services that help biopharma manufacturers convert legacy stainless-steel processes into single-use formats while maintaining or improving titer and product quality. Sartorius highlights reduced turnaround times, lower cleaning validation burden and increased manufacturing flexibility as key benefits, especially for multi-product facilities and contract development and manufacturing organizations handling a broad client portfolio and frequent campaign changeovers. This positioning has made BIOSTAT STR a flagship in Sartorius’s upstream portfolio and a reference point for many new biologics facilities built around single-use infrastructure.

For Sartorius Stedim Biotech, BIOSTAT STR sits alongside Ambr systems in development labs and Biostat RM rocking-motion systems at smaller scales, forming a scalable family from early clone screening to commercial production. The company’s upstream segment, which includes bioreactors and associated single-use consumables, is a major contributor to its Bioprocess Solutions division, and the installed base of BIOSTAT STR systems drives recurring revenue from Flexsafe STR bag sales and related components. Shares of Sartorius Stedim Biotech (FR0013154002) closed on Euronext Paris at EUR 217.40 on 06/14/2026.

BIOSTAT STR single-use bioreactor in brief

• Product: BIOSTAT STR single-use bioreactor system
• Manufacturer: Sartorius Stedim Biotech SA
• Category: Flagship/Bestseller upstream bioreactor platform
• Launch date: First generation introduced in the early 2010s, with current 50-2,000 L range available after multiple upgrades
• MSRP / Price: Pricing varies by volume and configuration; individual systems typically in the mid six-figure EUR/USD range including control tower
• Availability: Available globally through Sartorius sales and service, with installations in North America, Europe and Asia-Pacific biopharma hubs
• Target audience: Biopharmaceutical manufacturers, CDMOs, vaccine producers and advanced therapy developers with large-scale mammalian cell culture needs
• Key differentiator / USP: End-to-end single-use stirred-tank platform up to 2,000 L with integrated automation and alignment to Sartorius upstream and downstream solutions

This article was a.i.-assisted and editorially reviewed. Product information without warranty; prices and availability may change at short notice. Not investment advice and not a buy or sell recommendation. Trading involves risk up to and including the total loss of invested capital.