The Challenge
A leading CGT CDMO in Austria faced the challenge of automating their manual inoculum production processes to ensure scalability and reproducibility for growing patient batches. The identified pain points were severe:
- Variability due to human factors: Process quality depended heavily on the operator’s performance (e.g., when detaching adherent cells by tapping the CellStack)
- Contamination risk: Every manual interaction in Upstream Processing increased the risk of human error and microbiological contamination
- Instrument complexity: The variety of containers (Falcon Tubes, Flasks), pipettes, and instruments made standard automation difficult
- Lack of scalability: Manual processes were difficult to scale up for larger patient batches without jeopardizing quality
The sensitive nature of cell and gene therapy products required a solution that not only increases efficiency but also guarantees highest purity and reproducibility.
Our Solution
Pharmabotix developed Sally – a highly flexible and modular automation solution specifically designed for the complex requirements of CGT inoculum production and laboratory processes:
System Architecture & Components:
- Robot-Assisted Precision: A 6-axis robot handles critical tasks such as opening and closing containers using specialized screwdrivers
- Modular Instrument Handling: Seamless integration of Falcon Tubes, Vials, and Flasks from 250 ml to 2000 ml
- Precise Pipetting: Automated pipetting in the volume range of 1 ml to 50 ml with highest accuracy
- Peripheral Integration: Seamless incorporation of third-party equipment such as centrifuges and incubators into the automated workflow
Technology Highlights:
- Proof of Concept: Successful demonstration of inoculum production under GMP-near conditions
- Flexibility: Rapid adaptation to different container geometries and process steps through modular design
- Plug & Produce: Simple commissioning minimizes downtime and enables immediate production start
- Real-Time Monitoring: Integrated status lights enable simple and direct process monitoring by personnel
GMP Compliance & Validation:
- Designed for strictest documentation and validation requirements in cell therapy manufacturing
- Complete traceability of all process steps
- Automated logging and reporting functions
Project Gallery
5 Images