Biobrain® Automation Platform
Biobrain® is a modularly designed automation platform tailored to the diverse needs of various process units in upstream processing, downstream processing, and fluid management. By combining the data benefits of reliable industrial hard- and software with a high degree of fully traced configurability and adaptability, Biobrain® can help bioprocess scientists keep up with the increasing demand for flexibility in the era of Bioprocessing 4.0.
The modern and easy-to-use interface is consistent across various applications.
A rich set of features - e.g., audit trail and batch reporting - help you achieve 21 CFR p11 compliance.
Integrated with process analytical technologies (PAT) and compatible with perfusion, multi-step, and continuous processing.
Connect to SCADA, DCS, and MES systems via phase- and recipe-level integration using modern standards and protocols.
Continuous release cycle with new features and improvements to maintain innovation.
Explore key Biobrain® features and discover how our local automation solution seamlessly integrates into your infrastructure and simplifies bioprocess control.
Biobrain® addresses the ever-increasing need for integrated production environments by providing powerful interfaces to higher-level systems (such as DCS, SCADA, MES or Historian Solutions) as well as infrastructural components.
Integration into higher-level systems is enabled by a strong standardized UPC UA interface, allowing phase-level (typically used for SCADA/DCS integration) and recipe-level interaction (typically used for MES systems) including process data, alarms, and events.
Biobrain® provides all relevant interfaces to key IT infrastructure environments such as time synchronization and file exchange servers, Centralized User Authentication, and Windows® domain integration.
Biobrain®-powered products provide advanced upward integration capabilities towards higher-level orchestration and data analytic layers for typical scenarios, including established SCADA, DCS, MES, and Historian solutions.
The Biostat STR® Generation 3 is a family of single-use bioreactors providing all process strategies, from classical batch to intensified processes, and cover all stages of the seed train up to the final production bioreactor with a working volume range from 12.5 L to 2,000 L.
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By its modular nature, the Biobrain® Automation platform enables a large variety of unit operations in pharmaceutical production environments. By its wide range of applications, Biobrain® reduces training efforts, increases operational safety, and harmonizes integration in diverse automation landscapes:
Biobrain® Automation Platform enables a fully flexible, modular seed train by powering the Biostat® RM and Biostat STR Generation 3 product families.
By powering unit operations in the Celsius® FFT Platform for Large Volumes and AliquoT® Automated Filling station, the Biobrain® Automation platform enables a harmonized, fully integrated end-to-end solution for Frozen Bulk Drug Substances handling.
Celsius® FFT AliquoT® Automated Filling
The Biostat® RM is a wave-mixing bioreactor proven for a broad range of cell lines, including CHO, HEK293, stem cells, and CAR-T cells. Customers working with shear-stress-sensitive cell lines and bioconjugates acknowledge the benefits of rocking motion technology.
Our highly experienced engineering consulting team can help you overcome integration challenges.
The Biobrain® platform is compliant with industry standards, and the structured release of updates, including bug fixes, cybersecurity, and new functionality, ensures the continued reliability and security of the system. The platform provides easy access and rollout to Sartorius innovations, e.g., new sensors across systems.
Biobrain® is based on the ISA-S88 standard for batch control, models, and terminology. This standard provides a consistent framework that can be used to describe plants and processes in a uniform structure, ensuring clarity and efficiency in your operations.
The software modules are developed and tested in strict accordance with the GAMP life-cycle approach. This aligns the system with GAMP 5 Category 4 standards for configurable software (DIN ISO 9000 quality management). This reduces (re-)qualification efforts.
Your data's security, integrity, and availability are our focus. As such, we prioritize cybersecurity for our software, ensuring data protection. We offer antivirus solutions for Biobrain® instruments and provide guidance on antivirus software.
Biobrain®-powered instruments provide a rich functional scope satisfying all requirements for implementation in regulated cGMP environments. Among the functionalities tailored for the deployment of Biobrain®-powered instruments in regulated environments are advanced access control, audit trail, alarms & event management, and batch management.
The administrator can define user roles with specific permissions.
Enhanced process safety by Audit-trail traced Operator guidance for relevant process steps, e.g., for sensor calibration, further eliminating the possibility of human error.
A bioprocess automation system requires a proper strategy to ensure safe and user-friendly operation, Biobrain® is based on an industrial Siemens Simatic S7-1500 PLC logic controller and Siemens WinCC open architecture (WinCC OA). Siemens I/O boards, as well as the usage of industrial interfaces like Profinet, ensure a reliable and durable hardware foundation.
Biobrain® is a modularly designed automation platform tailored to the diverse needs of various process units in upstream processing, downstream processing, and fluid management.
Biostat STR® Generation 3 Single-Use Bioreactors enhance speed, quality, control, and flexibility in process development and commercial manufacturing. Integrated Biobrain® software enables seamless monitoring and control.
The Biostat® RM rocking motion bioreactor system combines the established RM rocker devices with the new, first-in-class control tower based on the Biobrain® automation platform for advanced bioprocess control.
AliquoT® is a solution for accurate and reliable filling of bulk drug substances in single-use Celsius® containers with automation powered by Biobrain®.
Biobrain® enables users to tailor the system to the specific needs of individual processes. This includes:
Activating | deactivating certain actuators or sensors (e.g., pumps or balances)
Specifying specific control strategies
Adapting default values for parameters, setpoints, and alarm ranges
Users can store multiple instrument configurations on the device to enable effortless switching between different processes. In the example below, the same Biostat STR® Generation 3 product is tailored to different process scenarios.
For standard batch operation (e.g., for regular seed train use) only the relevant basic control loops and elements are activated e.g., sensors, actuators, and controllers regulating optical pH | DO, stirrer, vessel weight, foam control, and gassing.
The same control tower can be used for fed-batch operation by simply selecting a pre-configured fed-batch configuration which will activate the relevant additional control loops and elements.
The same tower can be used for process intensification by simply selecting a configuration that will activate additional control loops including permeate, media, and bleed flow, as well as ATF cell retention.
Automate your process execution by creating comprehensive and reliable recipes using BioPAT® MFCS recipe editor. Recipes can be transferred to the Biobrain®-powered instrument for local execution or remotely executed from BioPAT® MFCS SCADA.
Comfortably create and edit your recipes at your desk using the standalone BioPAT® MFCS software, which imports the capabilities of Biobrain®. BioPAT® MFCS recipe editor allows users to create comprehensive unit recipes using sequential and | or parallel branches, as well as jumps. User guidance steps and decision phases can be included to reduce operator failures.
Enhance the capabilities of your Biobrain®-powered product with seamless integration into BioPAT® MFCS 4 SCADA and unlock a host of additional functionalities such as remote control, multi-unit view, central monitoring & control, batch comparison, advanced recipes, and SIMCA connectivity.
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Be GMP-ready from the start with tight process control and seamless scalability.
Discover the benefits of scalable rocking motion technology for shear-sensitive cells.
Simplify freeze | thaw operations with single-use cold chain solutions.
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