Background
Developing advanced bioreactor systems for tissue engineering requires balancing process control, sterility, and adaptability. Traditional open systems present challenges in reproducibility and GMP compatibility, while custom solutions must address real-world constraints such as continuous metabolite monitoring.
CCRM Nordic’s Approach
CCRM Nordic partnered with a company developing a tissue-engineered product to design and implement a functionally closed bioreactor process, moving from proof-of-concept to a robust, testable workflow. Together, we developed a custom bioreactor system capable of handling blood vessels of various lengths, integrated real-time glucose monitoring, and iteratively optimized the control parameters. The project included comprehensive calibration, sterility testing, and troubleshooting of practical issues.
Our Contribution
What set this collaboration apart was our hands-on, solution-oriented approach. We delivered:
- A Proof-of-principle, functionally closed process with promising results, demonstrating compatibility with blood as a matrix for PAT sensors.
- Continuous process optimization, including calibration verification, PID tuning, and process automation for stable glucose monitoring.
- Sterility verification, with media-only runs and BactAlert testing confirming the effectiveness of EO treatment and guiding future GMP-readiness.
- Transparent documentation and tech transfer, ensuring all learnings and protocols are accessible for future development.
- Manufacturing implications mapping such as improved cleanroom throughput, decreased manual intervention and reduced risk of process failure.
Results and Impact
This partnership enabled the client to:
- Fabricate a proof-of-concept bioreactor for a reproducible, functionally closed process with stable control and verified sterility.
- Identify practical solutions to process challenges, accelerating the path toward GMP-compatible workflows.
- Build a foundation for further process development and scale-up, supported by detailed operational data and collaborative expertise.
By combining deep technical insight with pragmatic engineering, CCRM Nordic and the client have advanced the development of next-generation bioreactor systems for tissue engineering applications.