TAITEC C·BR-500S Rocking-Type Single-Use Bioreactor System

Overview

The TAITEC C·BR-500S is a rocking-type single-use bioreactor system engineered for scalable, process-integrated cell culture in early-stage biopharmaceutical development and clinical manufacturing. Unlike conventional CO₂ incubators or stirred-tank bioreactors, the C·BR-500S integrates controlled mechanical agitation—via precision see-saw rocking—with active gas exchange and optional non-invasive process analytics. Its core architecture supports perfusion- and batch-mode cultivation of suspension-adapted mammalian cells—including hybridomas, CHO, and HEK293 lines—within sterile, disposable 2D bioprocess bags (10 L, 20 L, or 50 L format; max. working volume 25 L). The system operates within a tightly regulated thermal envelope (+20 to +40 °C, ±0.5 °C accuracy), leveraging cross-flow low-particulate fans and programmable rocking parameters (3–12° tilt, 3–40 rpm) to ensure homogeneous mixing, efficient oxygen transfer, and consistent shear profile across the culture volume. Designed for GMP-aligned workflows, it serves as a bridge between bench-scale flask culture and large-scale stainless-steel bioreactors—enabling robust seed train expansion, vaccine antigen production, and monoclonal antibody process characterization.

Key Features

• Rocking-based agitation with independently adjustable angle (3–12°) and speed (3–40 rpm), optimized to maintain uniform suspension while minimizing hydrodynamic stress on sensitive suspension cells.
• Integrated O₂/CO₂ gas blending module with real-time concentration control (±1% accuracy) and tunable flow rates (80–500 mL/min), ensuring precise regulation of dissolved oxygen and pH via headspace composition.
• Non-invasive, optical DO and pH monitoring capability (optional)—enabled by proprietary sensor-integrated 2D bioprocess bags and external excitation/detection optics—eliminating membrane fouling, calibration drift, and sterilization-related sensor degradation.
• Stainless steel enclosure with IP-rated electrical safety, emergency stop, temperature cut-off, door interlock, and pressure monitoring—fully compliant with IEC 61010-1 for laboratory equipment safety.
• Single-bag configuration supporting up to 50 L total bag volume (25 L working volume), validated for high-density (>10⁷ cells/mL) suspension culture under controlled rocking and gas exchange conditions.
• Low-particulate internal air circulation via cross-flow fan—critical for maintaining ISO Class 5 cleanroom-compatible environments during extended operation.

Sample Compatibility & Compliance

The C·BR-500S is validated for use with TAITEC-certified single-use 2D bioprocess bags (10 L, 20 L, 50 L), manufactured from USP Class VI-compliant, extractables- and leachables-tested polyethylene film. These bags feature pre-installed optical sensor patches for DO and pH, enabling real-time, non-contact measurement without compromising sterility or bag integrity. The system meets essential requirements for GLP and early-phase GMP environments: temperature uniformity (±0.5 °C), traceable calibration protocols, and hardware-level safety interlocks aligned with ISO 13485 design controls. While not inherently certified for FDA 21 CFR Part 11 compliance, its data acquisition interface supports integration with third-party audit-trail-capable SCADA or MES platforms when paired with appropriate software validation packages.

Software & Data Management

The C·BR-500S operates via an embedded industrial controller with local HMI display for real-time parameter visualization (rocking status, temperature setpoint/actual, gas flow, alarm logs). All operational parameters—including rocking angle/speed, temperature, gas blend ratios, and (when equipped) DO/pH trends—are timestamped and exportable via USB to CSV or PDF formats. For integrated process data management, the system supports analog 4–20 mA or digital RS-485 outputs compatible with LabVIEW, DeltaV, or custom LIMS interfaces. Optional firmware upgrades enable remote monitoring via Ethernet (Modbus TCP), facilitating centralized oversight in multi-unit installations. All sensor data adhere to ASTM E2500-13 principles for analytical instrument qualification, and raw signal traces are preserved without interpolation or smoothing.

Applications

• Seed train expansion for upstream bioprocessing—particularly where scalability from T-flasks to 200–2000 L bioreactors demands empirical correlation of growth kinetics and metabolite profiles.
• Clinical-grade mAb and viral vector production at pilot scale (e.g., 5–25 L working volume), supporting Phase I/II material generation under quality-controlled conditions.
• Vaccine antigen expression (e.g., influenza HA, SARS-CoV-2 spike protein) in suspension-adapted cell lines, leveraging enhanced mass transfer from rocking-induced surface renewal.
• Process characterization studies—including DO setpoint optimization, pH shift experiments, and feeding strategy evaluation—using identical bag geometry across scales to minimize scale-up risk.
• Comparative bioprocess modeling: C·BR-500S datasets provide high-fidelity inputs for computational fluid dynamics (CFD) simulations of rocking bioreactor hydrodynamics and oxygen transfer coefficients (k_La).

FAQ

Does the C·BR-500S support humidity control?
No—humidity regulation is not implemented. Users requiring controlled relative humidity must operate the system within an externally conditioned environment (e.g., climate-controlled cleanroom or environmental chamber).
Are sensor-integrated bags included with the base system?
No—DO/pH sensor bags are optional accessories, sold separately. Bag customization (e.g., additional sensor ports, tubing configurations, or connector types) is available upon request and subject to minimum order quantities.
Can the C·BR-500S be operated below ambient temperature?
Only if connected to an external chilled water supply; the unit lacks integral refrigeration. When ambient temperature exceeds setpoint by more than 7 °C, cooling water (≤15 °C) must be supplied to maintain thermal stability.
What regulatory documentation is provided with the system?
Each unit ships with a Factory Acceptance Test (FAT) report, CE Declaration of Conformity, electrical safety certificate (IEC 61010-1), and material compliance statements (RoHS, REACH, USP Class VI). IQ/OQ protocol templates are available upon request.
Is remote software update capability supported?
Firmware updates require local USB media and manual initiation via the HMI. Over-the-air (OTA) updates are not supported for cybersecurity and validation integrity reasons.