Cytiva Sepax C-Pro Automated Cell Processing System

Overview

The Cytiva Sepax C-Pro Automated Cell Processing System is a closed, fully automated platform engineered for robust, reproducible, and regulatory-compliant cell processing in clinical- and commercial-scale cell therapy manufacturing. It operates on patented axial centrifugation technology — a low-shear, gravity-independent separation principle that maintains cell viability and functionality while enabling precise control over sedimentation dynamics within disposable processing chambers. Unlike conventional swing-bucket or fixed-angle centrifuges, the Sepax C-Pro applies controlled rotational force along the longitudinal axis of the centrifuge cup, allowing continuous, programmable fluidic manipulation of cell suspensions during rotation. This architecture supports integrated, sequential unit operations — including concentration, washing, dilution, magnetic bead incubation, density gradient separation, spinoculation, and final formulation — all within a single, sealed, single-use fluid path. Designed specifically for autologous and allogeneic cell therapy workflows, the system meets stringent requirements for Good Manufacturing Practice (cGMP), ISO 13485, and EU Annex 1 for sterile processing of advanced therapy medicinal products (ATMPs).

Key Features

• Fully closed, single-use fluidic architecture minimizes operator intervention and eliminates open-handling risks — critical for maintaining sterility and reducing adventitious agent contamination.
• Modular, programmable process execution via Sepax C-Pro software enables rapid reconfiguration between protocols without hardware modification.
• Integrated axial centrifugation delivers high-resolution separation of heterogeneous cell populations (e.g., T cells, NK cells, mononuclear cells) with minimal mechanical stress and consistent yield across runs.
• Compact footprint (≤0.8 m²) and intuitive touchscreen interface reduce facility space requirements and accelerate operator training cycles.
• Real-time monitoring of critical process parameters — including rotational speed, temperature, pressure differentials, and fluid volume — with configurable alarm thresholds and event logging.
• Compliance-ready design supporting 21 CFR Part 11 electronic records and signatures when deployed with Chronicle eSOP, including full audit trail, user access control, and electronic signature capture.

Sample Compatibility & Compliance

The Sepax C-Pro accommodates a broad range of starting materials, including fresh or cryopreserved leukapheresis products, whole blood, bone marrow aspirates, and expanded cell cultures. Its disposable kits are validated for volumes from 20 mL to 500 mL and support both manual and automated loading configurations. The system complies with IEC 61010-1 (safety of laboratory equipment), IEC 61326-1 (EMC for in vitro diagnostic medical devices), and IEC 62304 (medical device software lifecycle). It carries CE marking under the Machinery Directive 2006/42/EC and conforms to GAMP 5 principles for computerized system validation. All process-critical software modules undergo rigorous verification per ICH Q5A(R2) and USP <1043> guidelines for cellular therapies.

Software & Data Management

The Sepax C-Pro Control Software provides role-based access, protocol versioning, and step-by-step guided operation with visual feedback at each stage. Process data — including timestamps, sensor readings, actuator statuses, and alarm events — are exported in CSV or XML format and synchronized with Chronicle eSOP for electronic batch record (EBR) generation. Audit trails meet ALCOA+ criteria (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) and support GLP/GMP inspections. Remote monitoring is enabled via secure HTTPS connection; integration with MES or LIMS systems is supported through standard OPC UA or RESTful API interfaces. Change Control Notifications (CCN) are delivered via web portal subscription to ensure timely awareness of firmware updates, kit revisions, or regulatory impact assessments.

Applications

The Sepax C-Pro is routinely deployed in CAR-T and NK cell manufacturing workflows, including CD3-negative/CD56-positive selection using BeadWash C-Pro-compatible magnetic reagents. It enables closed, automated removal of platelets and plasma from leukapheresis products, followed by density gradient isolation of mononuclear cells (MNCs), magnetic bead-based enrichment, and final formulation into cryobags or culture vessels. In spinoculation applications, it performs simultaneous concentration, buffer exchange, and lentiviral transduction under controlled g-force conditions. The system also supports post-thaw processing of cryopreserved products, including washing, resuspension, and precise volumetric dispensing into multiple culture bags — all traceable and compliant with EMA CAT/ICH guidelines for ATMP release testing.

FAQ

Does the Sepax C-Pro require dedicated cleanroom infrastructure?
No — its closed-system design and Class A air filtration option allow deployment in Grade C or better environments; full integration with isolator systems is supported.
Can the Sepax C-Pro be used for non-clinical research applications?
Yes — while optimized for cGMP production, its flexibility supports preclinical process development, scale-down modeling, and analytical method qualification.
Is remote validation support available for the Sepax C-Pro?
Yes — Cytiva offers IQ/OQ/PQ documentation packages, risk assessments (FMEA), and on-site or virtual commissioning services aligned with Annex 15 and ASTM E2500.
What consumables are required for routine operation?
Only certified, gamma-irradiated, RNase/DNase-free Sepax C-Pro disposable kits — no third-party tubing, filters, or centrifuge cups are validated or supported.
How does the system handle deviations during a run?
It triggers immediate pause-and-hold with cause-specific alerts, logs all deviation events with contextual metadata, and permits authorized users to resume, abort, or reprocess based on predefined SOP logic.