ATMP, Cell Therapy and Regenerative Medicine systems for R&D and cell factories. Incubation Systems, Cell Culture Isolators, and more, all customizable.
Semi-automatic and refrigerated bag aseptic filling system for Cell & Gene applications
ATMP, Cell Therapy and Regenerative Medicine systems for R&D and cell factories. Incubation Systems, Cell Culture Isolators, and more, all fully customizable. After all, we are customization experts.
Our product lines address needs in cell therapy production, incubation system, decontamination. lab management, testing and validation.
Advanced Therapy Medicinal Products (ATMPs) include gene therapy, cell therapy and tissue-engineered products. They are manufactured according to GMP guidelines. Our equipment is fully GMP compliant.
Since the products consist of living cells, the manufacturing process is different from traditional pharma products. One aspect is that these products cannot be sterilized.
EU Guidelines for ATMPs state that they must be handled in a Grade A environment.
Our isolators are closed environments with guaranteed Grade A. This removes the risk of contamination. The internal environment also provides a controlled atmosphere with specific ventilation and filtration strategies. The ventilation strategy includes laminar airflow with HEPA H14 filters, positive pressure, H14 exhaust filters and a high rate of recirculation. Decontamination happens with H2O2 gas, and different cycles are applied to different parts of the isolator.
Isolation technology solutions increase sterility and contamination control while decreasing costs and energy consumption.
A series of incubation modules integrated into a docking station, which provides shared utilities to the modules, like electricity, humidified hot air, CO2, decontamination, etc.
The system can be placed in a grade D environment, with clear saving in terms of classification of environments.
Modules can be transferred to an isolator for handling operations.
The system is called FlexyCult, perfect for scaling ATMP production processes.