Cytiva UniFlux Tangential Flow Filtration (TFF) System

Overview

The Cytiva UniFlux Tangential Flow Filtration (TFF) System is an automated, scalable platform engineered for robust, reproducible, and GMP-aligned microfiltration and ultrafiltration operations across pilot-scale to commercial manufacturing environments. Unlike dead-end filtration, tangential flow filtration maintains a controlled cross-flow velocity parallel to the membrane surface—minimizing fouling, sustaining flux stability, and enabling high-recovery processing of sensitive biologics such as monoclonal antibodies, viral vectors, plasmid DNA, and vaccine candidates. The system operates on well-established hydrodynamic principles: feed solution circulates tangentially across the membrane under precise pressure control; particles or macromolecules larger than the membrane’s nominal molecular weight cutoff (NMWC) are retained in the retentate loop, while permeate (buffer, salts, small metabolites) passes through the membrane. This closed-loop architecture supports continuous concentration, buffer exchange (diafiltration), and clarification with minimal shear stress and consistent mass transfer characteristics.

Key Features

• Modular scalability: Four standard flow rate configurations (10, 60, 120 L/min); 400 L/min available via engineered customization for large-batch processing.
• Flexible vessel integration: Compatible with stainless-steel tanks (5–600 L) or single-use mixing systems—enabling rapid changeover and reduced cleaning validation burden.
• UNICORN-based automation: Full process scripting, real-time parameter monitoring (transmembrane pressure, differential pressure, flow rate, temperature, conductivity), and event-driven logic execution.
• Regulatory-ready architecture: Pre-validated UNICORN software compliant with FDA 21 CFR Part 11, supporting electronic signatures, audit trails, and secure data archiving for GLP/GMP environments.
• Hardware interoperability: Designed for seamless integration with Cytiva’s broader purification ecosystem—including ÄKTA chromatography platforms—ensuring consistent operator training and unified data handling.

Sample Compatibility & Compliance

The UniFlux system accommodates a broad range of commercially available TFF devices, including hollow-fiber modules (e.g., Xampler, KrosFlo series) and cassette-style membrane packs (e.g., Pellicon, Viresolve Pro). It supports NMWC ranges from 10 kDa (ultrafiltration) to 0.2 µm (microfiltration), making it suitable for mammalian cell harvest, microbial lysate clarification, virus removal, and final formulation buffer exchange. All hardware components meet ASME BPE-2021 surface finish standards (Ra ≤ 0.4 µm electropolished stainless steel), and fluid-contact materials comply with USP Class VI and FDA 21 CFR 177.2600 requirements. System qualification packages—including IQ/OQ documentation templates—are provided to support compliance with ICH Q5A(R2), ISO 26315, and EU Annex 1 for sterile bioprocessing.

Software & Data Management

UNICORN software serves as the central control and data management layer. It enables creation of validated, version-controlled method files with embedded alarms, interlocks, and deviation logging. All process parameters—including real-time transmembrane pressure (TMP), retentate and permeate flow rates, and conductivity trends—are timestamped and stored in encrypted binary format with SHA-256 integrity verification. Data export options include CSV, PDF reports, and direct integration with LIMS or MES via OPC UA. Audit trail functionality records user actions, parameter changes, and system events with immutable timestamps—fully traceable for regulatory inspections. UNICORN also supports electronic signature workflows aligned with ALCOA+ data integrity principles.

Applications

• Upstream clarification: Harvest of CHO, HEK293, or insect cell cultures using 0.2–0.65 µm microfiltration cassettes.
• Downstream concentration & diafiltration: Final polishing step prior to chromatography or fill-finish, particularly for mAbs, bispecifics, and fusion proteins.
• Viral vector processing: Concentration and buffer exchange of AAV or lentivirus preparations without aggregation or infectivity loss.
• Plasmid DNA purification: Tangential flow diafiltration following alkaline lysis and RNase treatment to achieve endotoxin removal and isotonic formulation.
• Process development transfer: Method translation from benchtop (ÄKTA readyflux) to pilot-scale (UniFlux) using identical UNICORN methods and sensor calibration protocols.

FAQ

Is the UniFlux system compatible with single-use fluid paths?
Yes—the system supports fully disposable flow paths, including single-use pumps, tubing assemblies, sensors, and mixing vessels, minimizing cross-contamination risk and eliminating cleaning validation requirements.
Can UNICORN methods be transferred between UniFlux and ÄKTA chromatography systems?
Yes—UNICORN method files are portable across Cytiva platforms. Parameter scaling (e.g., flow rate, column volume equivalents) is managed via built-in unit conversion tools and dimensionless number mapping (e.g., Reynolds, Sherwood numbers).
What regulatory documentation is included with the system?
Standard delivery includes Factory Acceptance Test (FAT) report, IQ/OQ protocol templates, UNICORN 21 CFR Part 11 validation package, and material compliance certificates (USP Class VI, FDA 21 CFR 177.2600).
How does Cytiva support long-term system maintenance and lifecycle management?
OptiRun service agreements provide tiered support—including remote diagnostics, scheduled preventive maintenance, spare parts logistics, and change control notification (CCN) subscriptions via Cytiva’s Regulatory Support Portal.
Is remote monitoring and troubleshooting supported?
Yes—via Cytiva Connect, a secure cloud-enabled interface that allows authorized personnel to monitor live process metrics, review historical trends, and initiate diagnostic routines with technician assistance.