Applitech AbioSUS® Single-Use Bioreactor
| Brand | Applitech |
|---|---|
| Origin | Guangdong, China |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Product Category | Domestic |
| Model | AbioSUS® Single-Use Bioreactor |
| Volume Options | 50 L, 200 L, 500 L, 1000 L, 2000 L |
| Temperature Control Range | 8–40 °C ±0.1 °C (with chilled water ≤8 °C) |
| Weighing Accuracy | C6-class load cell system |
| Bag Material | 7-layer co-extruded film, USP Class VI & ISO 10993 compliant |
| Stirring System | Dual marine impeller configuration |
| Aeration | Dual bottom gas inlets (0.8 mm coarse sparger + 150 µm microsparger) |
| Control Platform | AbioControl® IDS.S modular controller with 5-tier user permissions and 21 CFR Part 11-compliant audit trail |
Overview
The Applitech AbioSUS® Single-Use Bioreactor is an engineered solution for scalable upstream bioprocessing, integrating stainless-steel hardware architecture with single-use disposable bag technology to bridge the gap between traditional stirred-tank reactors and modern process flexibility. Designed around classical bioreactor hydrodynamics—including optimized aspect ratio, impeller positioning, and fluid mixing profiles—the AbioSUS® platform ensures high process consistency across scales. Its core architecture comprises a double-jacketed stainless-steel vessel with integrated Thermo-Control Unit (TCU), the AbioControl® IDS.S automation system, and the AbioBag® single-use cultivation bag. This hybrid design enables direct comparability with legacy stainless systems during tech transfer, significantly reducing qualification timelines for process development, clinical manufacturing, and commercial production of monoclonal antibodies, viral vaccines, and cell/gene therapy products.
Key Features
- Stainless-steel vessel with double-jacketed tank and door—enabling uniform temperature distribution via closed-loop water circulation; TCU integration eliminates external heating/cooling units and incorporates thermoelectric cooling (TEC) for overtemperature protection.
- AbioBag® single-use bags fabricated from 7-layer co-extruded film (320 µm total thickness), featuring ultra-low-density polyethylene (ULDPE) inner layer for biocompatibility, mechanical robustness, and compliance with USP Class VI and ISO 10993 biological safety standards.
- Dual marine impeller stirring system—optimized for shear-sensitive mammalian and stem cell cultures across all volume ranges (50–2000 L), ensuring homogenous mixing while minimizing hydrodynamic stress.
- Dual bottom gas inlets supporting concurrent or switchable operation between 0.8 mm coarse sparging (for bulk oxygen transfer) and 150 µm microsparging (for enhanced kLa, improved pH control, and reduced foaming).
- C6-grade load cell system with removable support stand—protects sensors during storage or transport; stand is disengaged during operation to enable direct weight-based mass monitoring of culture medium.
- Large single-door access with full-view optical window and calibrated scale markings—facilitates rapid bag installation, visual inspection, and real-time observation of culture morphology and foam behavior.
- Sensor interface zone positioned per ASME BPE and ISPE guidelines—ensures reproducible placement of both reusable (glass pH, polarographic DO) and single-use electrodes, with dual-pH/dual-DO capability for redundancy and calibration verification.
Sample Compatibility & Compliance
The AbioSUS® platform supports suspension and adherent cell cultures—including CHO, HEK293, CAP-T, and primary human T cells—across fed-batch, perfusion, and transient transfection workflows. All wetted materials are animal-component-free and certified non-pyrogenic. The AbioBag® meets ISO 10993-5 (cytotoxicity), -10 (irritation/sensitization), and -11 (hemocompatibility) requirements. System-level validation includes Computational Fluid Dynamics (CFD)-based performance qualification confirming uniform mixing time (θm), oxygen mass transfer coefficient (kLa), and low-shear velocity gradients (<50 s−1) within critical zones. Full documentation packages—including material traceability, extractables/leachables reports, and bioburden testing—support regulatory submissions under ICH Q5A, Q5B, and FDA guidance for single-use systems.
Software & Data Management
The AbioControl® IDS.S controller delivers deterministic process control through PID and cascade loops for temperature, agitation, pH, DO, and gas flow. It features five-tier role-based access control (View, Operator, Engineer, Supervisor, Administrator), tamper-resistant audit trails compliant with 21 CFR Part 11, and secure electronic signatures. Real-time data logging occurs at configurable intervals (event-triggered or fixed sampling), with built-in UPS-backed 24 V DC power ensuring uninterrupted acquisition. Integration is enabled via Modbus RTU/TCP and 4–20 mA analog I/O for third-party devices—including mass flow controllers, balance systems, and off-gas analyzers. For enterprise-scale deployment, the AbioPIMS® Process Information Management System provides centralized batch data aggregation, cross-site synchronization, and ALCOA+ compliant data integrity. AbioPIMS® supports OPC UA connectivity, customizable alarm logic (HH/H/L/LL), trend-based deviation detection, and automated report generation—including PDF/Excel exports with embedded metadata and digital signatures.
Applications
The AbioSUS® bioreactor serves as a unified platform across the biomanufacturing lifecycle: early-stage process development (50–200 L), clinical lot production (500–1000 L), and commercial-scale manufacturing (2000 L). It is routinely deployed in upstream processes for recombinant protein expression, lentiviral vector production, CAR-T expansion, and microbial fermentation of therapeutic enzymes. Its compatibility with both reusable and single-use sensors—combined with flexible gas blending, precise feed control, and adaptive agitation strategies—supports complex feeding regimens, pH-stat DO-stat cascades, and dynamic perfusion protocols. The system’s modularity allows seamless integration into existing facility infrastructure, including cleanroom-compatible utility connections and GMP-aligned operational procedures.
FAQ
Can AbioSUS® be qualified for GMP manufacturing?
Yes—full IQ/OQ/PQ documentation packages, including sensor calibration records, CFD validation reports, and material certifications, are provided to support GMP compliance under EU Annex 1 and FDA CGMP requirements.
Is remote monitoring supported?
Yes—AbioPIMS® enables secure web-based access to real-time parameters, historical trends, and alarm status via TLS-encrypted HTTPS connections, with configurable user permissions and session timeouts.
What level of scalability assurance does AbioSUS® provide?
Process consistency is validated across volumes using dimensionless numbers (e.g., constant P/V, NRe, and kLa scaling), with empirical data demonstrating <±10% variation in viable cell density, titer, and metabolite profiles from 50 L to 2000 L.
Does the system support PAT (Process Analytical Technology) integration?
Yes—AbioControl® IDS.S supports analog/digital inputs from Raman, NIR, and capacitance probes; AbioPIMS® enables real-time multivariate analysis (MVA) and soft-sensor modeling for critical quality attributes (CQAs).
Are custom bag configurations available?
Yes—custom port layouts, tubing sets, filter housings, and sensor integration options are available under NDA, with lead times aligned to client project timelines and regulatory review cycles.
