Thermo Scientific HyPerforma Integrated Single-Use Bioreactor (SUB) System
| Brand | Thermo Scientific |
|---|---|
| Origin | USA |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Product Origin | Imported |
| Model | HyPerforma SUB |
| Material | Stainless Steel |
| Available Volumes | 50 L, 100 L, 250 L |
| Volume Ratio | 5:1 |
| Controller Platform | Finesse G3Lite Bioreactor Controller |
| Integrated Components | Finesse TruBio™ Software, Laudа TCU, TruTorr™ Pressure Transmitter, Disposable Electrochemical Sensors, Load Cells (up to 3), Mass Flow Controllers (6 total), Watson-Marlow Pumps (3 × WM114, 1 × WM313) |
Overview
The Thermo Scientific HyPerforma Integrated Single-Use Bioreactor (SUB) System is an engineered, ready-to-use, jacketed bioprocessing platform designed for robust and scalable mammalian cell culture operations. Based on classical stirred-tank reactor hydrodynamics—including optimized aspect ratio, impeller geometry, and axial mixing characteristics—the HyPerforma SUB preserves the fundamental mass transfer and shear environment of stainless-steel bioreactors while eliminating cleaning-in-place (CIP) and sterilization-in-place (SIP) validation burdens. Its fully integrated architecture combines a pre-sterilized single-use bag (BPC) with a modular, standalone Finesse G3Lite controller and a Lauda temperature control unit (TCU), enabling rapid deployment in R&D, early-stage process development, and clinical manufacturing environments. The system operates under controlled aerobic conditions with precise regulation of dissolved oxygen (DO), pH, temperature, agitation, feed addition, and headspace pressure—critical parameters for high-titer monoclonal antibody (mAb) production and viral vector manufacturing.
Key Features
- Pre-validated, gamma-irradiated single-use bags (BPCs) constructed from CX5-14 or Aegis5-14 film—tested per BioPhorum Operations Group (BPOG) guidelines for extractables and leachables (E&L)
- Engineered for compatibility with adherent and suspension cell lines including CHO, NS0, hybridoma, insect (Sf9, Sf21), Per.C6®, HEK293, MDCK, and Vero
- Finesse G3Lite controller with modular I/O architecture supporting up to 3 load cells, 6 mass flow controllers (MFCs), and 4 Watson-Marlow peristaltic pumps (3 × WM114, 1 × WM313)
- Integrated TruTorr™ pressure sensing, disposable DO/pH electrodes, and real-time thermal monitoring via embedded temperature transmitters
- Touchscreen HMI with intuitive navigation, alarm logging, and full audit trail capability compliant with FDA 21 CFR Part 11 requirements
- Scalable volume range: 50 L, 100 L, and 250 L working volumes with consistent geometric similarity (5:1 adjustment ratio)
Sample Compatibility & Compliance
The HyPerforma SUB supports both fed-batch and perfusion modes across diverse upstream bioprocess applications. Its BPC films meet USP Class VI and ISO 10993-5 cytotoxicity standards, and have undergone rigorous E&L testing per BPOG protocols—ensuring low risk of product contact surface interference. The system’s control architecture conforms to ICH Q5A(R2) and Q5D guidance for cell line characterization and culture condition consistency. All electronic records—including sensor calibration logs, setpoint changes, and alarm events—are timestamped and digitally signed, supporting GLP/GMP-compliant workflows and regulatory submissions. The G3Lite controller’s firmware is validated per ASTM E2500-13 and aligns with Annex 11 (EU GMP) and ISPE GAMP® 5 principles.
Software & Data Management
Finesse TruBio™ software provides a unified interface for recipe management, real-time trending, multivariable control loop tuning, and batch report generation. It supports structured data export in CSV and PDF formats, and integrates natively with enterprise systems via OPC UA and Modbus TCP protocols. Audit trails capture user identity, action timestamp, parameter value before/after change, and reason-for-change fields—fully traceable for FDA inspections. Historical data storage is configurable with automated backup to network drives or cloud-based repositories meeting HIPAA and GDPR retention policies.
Applications
- Early-phase process development for therapeutic proteins, vaccines, and gene therapy vectors
- Clinical manufacturing of Phase I–III biologics under cGMP conditions
- High-throughput clone screening and media optimization studies
- Perfusion-based continuous biomanufacturing with integrated cell retention systems
- Process characterization and comparability studies during technology transfer
FAQ
Is the HyPerforma SUB compatible with existing stainless-steel infrastructure?
Yes—the system interfaces seamlessly with standard utility connections (compressed air, nitrogen, CO₂, cooling water) and can be installed within existing cleanroom footprints without structural modification.
What validation documentation is provided with the system?
Each HyPerforma SUB shipment includes a Certificate of Conformance, BPC E&L test reports, controller IQ/OQ documentation templates, and sensor calibration certificates traceable to NIST standards.
Can the G3Lite controller operate independently of the HyPerforma SUB?
Yes—it is a fully autonomous platform capable of controlling third-party single-use or stainless-steel vessels when configured with appropriate I/O modules and sensor interfaces.
Does the system support remote monitoring and troubleshooting?
Remote access is enabled via secure TLS-encrypted web interface or VPN-connected desktop client, allowing real-time visualization, alarm acknowledgment, and limited parameter adjustment under defined user privilege levels.
Are replacement BPCs supplied with pre-installed sensors?
All standard BPC configurations include factory-integrated, gamma-sterilized pH and DO sensors; optional configurations support pre-installed temperature probes and pressure transducers.
