CellFac™ — Full-Process Immune Cell Production in a Grade A Closed Environment

Bring your SOPs into a closed, aseptic system that simulates human hand operations—from isolation and activation to expansion, formulation, and fill.
CellFac™ delivers cleanroom-grade control with robotic consistency to improve yield, traceability, and time-to-clinic.

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Why teams struggle to scale immune cell production

• Open handling risks contamination and batch failure.

• Manual steps introduce variability and operator fatigue.

• Fragmented devices slow tech transfer and training.

• Regulatory documentation is time-consuming to maintain.

How CellFac™ solves it

• Grade A (ISO 5) closed chamber with continuous environmental monitoring.

• Human-like robotic operation for pipetting, transfers, mixing, and cap/decap.

• End-to-end workflow orchestration from isolation to fill-finish—no open breaks.

• Digital traceability with barcode/RFID, audit trails, and electronic batch record export.

Designed to match your SOPs—then make them faster

CellFac™ replicates your validated methods with robotic precision—then adds automation, in-line QC, and data capture to scale your program.

Highlights

• Aseptic by design: ISO Class 5 laminar flow, HEPA filtration, and decontamination cycles.

• Robotic “gloved hands”: fine motor tasks including pipetting, capping/decapping, and mixing.

• Modular stations: isolation, activation, expansion, harvest, formulation, and fill.

• In-line sensing: temperature, pH/DO, weight, and optical checks.

• Digital batch records: role-based access, audit trails, and PDF/EBR export.

• IT/OT integration: REST API, OPC UA, SDK for MES/LIMS and SCADA systems.

End-to-end workflow coverage

• Cell isolation: leukapheresis input, wash, enrichment

• Activation & modification: bead-based activation, viral transduction

• Expansion: controlled mixing, media exchange, sampling

• Formulate & fill: concentration, buffer exchange, aseptic vial/bag fill

Technical specifications

Environment

• Grade A (ISO Class 5) laminar flow chamber

• Background installation: Grade B recommended

• HEPA H14 filtration, particle & pressure monitoring

• VHP/chemical decontamination cycles

Automation & control

• Human-like robotic manipulators with teach-by-demo

• Vision assistance for placement & verification

• Role-based access, 21 CFR Part 11-ready records

• Connectivity: REST API, OPC UA, SDK

Materials & utilities

• 316L stainless & cleanable glass/acrylic panels

• GMP-aligned gaskets & seals

• Electrical: 110–240V, 50/60 Hz; Air/Vacuum optional

Throughput & scale

• Process 1–N batches with parallelizable modules

• Supports research, clinical, and small-scale commercial runs

• Custom fixtures for bags, vials, and sterile closed sets

Built for teams that need speed, sterility, and scale

• Translational research: rapid method development with teach-by-demo.

• Clinical manufacturing: closed handling and digital records streamline QA.

• CDMOs & hospitals: standardize training, reduce error, and expand capacity.

Validation & compliance support

We provide documentation packages to accelerate qualification—URS templates, risk assessments, IQ/OQ checklists, and sample batch records—to align with your quality system.

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