Client Confidential
Cell Therapy Manufacturing Platform
Cell therapies, particularly CAR-T, represent a breakthrough in treating cancers and infectious diseases, but today’s manufacturing processes are labor-intensive, costly, and difficult to scale, limiting patient access.
Our team partnered with a client to develop a fully closed, automated cell therapy manufacturing platform designed to enable decentralized, point-of-care (POC) production. The system integrates two complementary instruments. One for cell isolation activation and formulation, and the second one for cell activation, expansion and formulation. The two instruments can operate independently or as a unified, digitally and fluidically connected platform.
1. Cell Isolation & Formulation Instrument
Designed for early-stage processing, this instrument performs:
- Cell isolation, activation, transduction, and formulation
- Multi-input/output fluidic management via peristaltic pumps and sensors
- Controlled environmental conditions (4°C – 37°C, CO₂ regulation)
- Real-time automated sampling for QA and analysis
2. Cell Expansion & Formulation Instrument
Designed for downstream processing and scale-up, this instrument supports:
- Cell activation, expansion, and final formulation
- Suspension or settled cell expansion using bioreactor systems
- Expanded sensing capabilities (temperature, DO, CO₂, pH, cell density)
- Precise environmental control (20°C–37°C, CO₂ regulation)
- Automated fluid handling and sampling
Contributions
- User research and system requirements development
- Industrial design and workflow-driven architecture
- Mechanical design of fluidics, motion, and enclosure systems
- Electronics and control system integration
- Embedded firmware and user interface development
- Prototype development and system-level testing
- Regulatory strategy and design documentation support
Impact
A compact, scalable system engineered for GMP-compliant production, improved workflow efficiency, and reliable, repeatable process control without the need for traditional cleanroom infrastructure.
TAGS
INDUSTRIAL DESIGN
MECHANICAL ENGINEERING
ELECTRICAL ENGINEERING
SOFTWARE ENGINEERING
EMBEDDED FIRMWARE
USABILITY ENGINEERING
USER INTERFACE DEVELOPMENT
QUALITY AND REGULATORY
PROJECT MANAGEMENT
TOOLS
SolidWorks
Rhino
Altium
Jump
Clinical Cell Isolation & Formulation Instrument
Engineering Challenges
Developing a fully automated, closed cell therapy system required solving for:
- Integration of fluidics, motion, environmental control, and sensing in a compact footprint
- Reliable operation with single-use consumables and sterile interfaces
- Maintaining sterility and closed-system operation
- Precise environmental control across varying process stages
- Complex fluid routing with multiple inputs and outputs
- Scalable architecture supporting both standalone and integrated operation
- Regulatory and documentation requirements for clinical manufacturing systems
Engineering & Design Approach
1. User Research & Requirements Definition
We began with deep user and market research:
- Site visits to clinical and manufacturing environments
- Interviews with operators and stakeholders
- Workflow mapping and use-case definition
This informed:
- Market requirements documentation
- Technical requirements and system architecture
- Regulatory strategy planning
2. Industrial Design & User Interaction
We developed a cohesive industrial design language, focused on:
- Clean, approachable form factors for clinical environments
- Clear process visibility and intuitive access points
- Touchscreen-driven workflows for protocol selection and operation
- Simplified setup, operation, and cleaning
Design concepts were iterated through renders and physical prototypes informed by user interaction studies.
3. Mechanical Architecture & System Integration
Mechanical engineering focused on integrating complex subsystems into a sealed, production-ready architecture:
- Closed single-use cartridge and tubing systems
- Motion platforms for agitation and mixing
- Fluidic management systems with pumps and sensors
- Environmental control systems (thermal and gas regulation)
- Sealed enclosures with lids for controlled processing environments
The system was engineered for:
- Sterility and contamination control
- Serviceability and ease of use
- Injection-molded components and scalable manufacturing
4. Electronics & Controls Architecture
We developed a comprehensive electronics platform to support automation and system integration:
- Custom PCBs for motor control, pump systems, and environmental control
- Single-board computer for touchscreen interface and system control
- NFC-based cartridge detection for error-proofing and traceability
- Network connectivity for data logging and system integration
The electronics architecture enabled reliable coordination of motion, fluidics, sensing, and user interface.
5. Embedded Firmware & User Interface
The platform is driven by a fully integrated firmware and UI system:
- Automated control of fluidics, motion, and environmental conditions
- Protocol-based operation for repeatable processes
- Real-time monitoring and control of system parameters
- Data collection, storage, and network integration for QA and traceability
- Touchscreen UI for process setup, execution, and monitoring
6. Prototyping, Integration & Validation
We developed multiple generations of functional prototypes:
- Technology feasibility platforms for concept and process verification
- Early breadboards for electronics and firmware development
- Subsystem prototypes for fluidics, motion, and environmental control
- Fully integrated systems for EVT/DVT evaluation and user studies
Validation included:
- End-to-end process testing: leukopak or whole blood through formulation
- Real-world testing with clinicians at customer sites
- Verification of automation, reliability, and process repeatability
7. Regulatory & Documentation Support
Given the clinical application, we supported:
- Regulatory strategy development
- Design documentation aligned with FDA guidance
- Design History File (DHF) preparation
RESULTS
The platform delivers a fully integrated, automated cell therapy manufacturing system capable of:
- Closed, sterile processing using single-use consumables
- Automated, repeatable workflows with minimal operator intervention
- Real-time monitoring and data traceability
- Scalable production from clinical to higher-throughput environments
- Operation outside traditional cleanroom facilities
The system successfully demonstrates a path toward decentralized, point-of-care cell therapy manufacturing, improving accessibility and reducing cost barriers.
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