Cellicon™ Cell Retention Solution
| Brand | Merck |
|---|---|
| Origin | USA |
| Manufacturer Type | Authorized Distributor |
| Product Category | Imported |
| Model | Cellicon™ Cell Retention Solution |
| Pricing | Available Upon Request |
Overview
The Cellicon™ Cell Retention Solution is a benchtop perfusion system engineered for robust, scalable, and operationally efficient seed train intensification—specifically designed for N-1 bioreactor seeding applications in mammalian cell culture processes. It operates on the principle of tangential flow filtration (TFF), utilizing a single-use, flat-sheet membrane-based cell retention device integrated with a dedicated process controller. Unlike conventional batch or fed-batch seeding strategies, Cellicon™ enables continuous perfusion at the seed bioreactor stage, maintaining high viable cell density (VCD) while minimizing metabolic waste accumulation. This approach supports consistent inoculum quality, reduces inter-batch variability, and enhances readiness for subsequent production-scale bioreactors. The system’s architecture prioritizes process control fidelity, low shear stress environment, and rapid setup—making it suitable for both early-stage process development and clinical manufacturing environments where reproducibility and regulatory traceability are critical.
Key Features
- Integrated TFF-based cell retention module with disposable flat-sheet membrane cassette—eliminates cleaning-in-place (CIP) and sterilization-in-place (SIP) validation burden
- Low-shear tangential flow design: optimized crossflow velocity ensures minimal hydrodynamic stress on sensitive mammalian cells (e.g., CHO, HEK293)
- Benchtop controller with programmable perfusion profiles, real-time monitoring of key parameters (flow rate, pressure differential, temperature, and harvest volume)
- Plug-and-play single-use fluid path: pre-assembled tubing sets, connectors, and sensor-integrated bags compliant with USP Class VI and ISO 10993 standards
- Linear scalability from lab-scale (1–5 L seed bioreactors) to pilot-scale (50–200 L), supported by consistent membrane surface area-to-volume ratios and identical hydrodynamic behavior
- Comprehensive audit trail capability aligned with FDA 21 CFR Part 11 requirements—including user authentication, electronic signatures, and immutable event logging
Sample Compatibility & Compliance
The Cellicon™ system is validated for use with suspension-adapted mammalian cell lines commonly employed in therapeutic protein production, including but not limited to CHO-K1, CHO-S, and AGE1.HN. It supports culture media formulations containing serum-free, chemically defined components and tolerates common additives such as Pluronic F-68 and recombinant human insulin. All wetted materials comply with USP and cytotoxicity testing, and the disposable assembly meets ISO 13485:2016 design control requirements. The system supports GLP- and GMP-aligned workflows, with documentation packages available for IQ/OQ/PQ execution and regulatory submission support (e.g., Module 3 technical sections for IND/IMPD dossiers).
Software & Data Management
The embedded controller runs proprietary firmware enabling closed-loop control of perfusion rate, bleed rate, and harvest volume based on user-defined VCD thresholds or time-based schedules. Data acquisition occurs at 1 Hz resolution and is exportable in CSV or ASAM MDF4 format for integration into enterprise systems (e.g., DeltaV, PATKnowledge, or MES platforms). Optional connectivity via OPC UA enables secure, firewall-compliant data routing to cloud-based analytics tools for multivariate process monitoring. All software modules undergo annual cybersecurity vulnerability assessment per IEC 62443-3-3 and include role-based access control (RBAC) to meet ALCOA+ data integrity principles.
Applications
- High-density N-1 seed train perfusion for monoclonal antibody (mAb) manufacturing, reducing lag phase and improving titer consistency across production bioreactors
- Recombinant protein production requiring tight control over glycosylation profiles—enabled by stable redox and nutrient conditions during extended perfusion
- Cell therapy upstream process intensification, particularly for transient transfection-based vector production (e.g., AAV, lentivirus)
- Process characterization studies supporting QbD frameworks, including DoE-driven evaluation of perfusion rate, harvest frequency, and media exchange ratios
- Accelerated tech transfer between R&D, clinical, and commercial sites through standardized hardware/software configuration and documented operational equivalence
FAQ
Is the Cellicon™ system compatible with existing bioreactor control platforms?
Yes—via analog 4–20 mA or digital Modbus RTU interfaces, allowing synchronization with major bioreactor vendors (e.g., Sartorius, Thermo Fisher, Eppendorf).
Can the system be used for perfusion in production-scale bioreactors?
Cellicon™ is intended for N-1 and intermediate-scale perfusion; for production-scale (≥1,000 L), Merck offers the Xcellerex™ XDR platform with scalable TFF integration.
What regulatory documentation is provided with the system?
Each shipment includes Device Master Record (DMR)-aligned certificates of conformance, material declarations, biocompatibility reports, and a complete validation support package (IQ/OQ templates, risk assessments, and URS traceability matrices).
How often must the disposable cassette be replaced?
Cassettes are designed for single-use per campaign (typically ≤14 days); replacement frequency depends on cell line-specific fouling behavior and is monitored via transmembrane pressure (TMP) rise rates.
Does the system support remote monitoring and alarm notification?
Yes—through optional Ethernet/Wi-Fi connectivity and configurable email/SMS alerts for critical events (e.g., pressure excursion, flow deviation >±10%, temperature drift).
