Birthed out of the company’s CC-IS isolator series, Tema has launched a new range that will be used for CAR-T therapies
Tema Sinergie has revealed a new range of isolators for Advanced Cellular Therapies and Regenerative Medicine (ATMP). The range comes from the company's CC-IS isolator series.
CC-IS is a Cell Culture, cGMP class A/ISO 5 isolator specifically designed to offer a safer environment than the one created in biosafety cabinets, clean booths and standard white rooms, writing off any risk of human contamination on cell crops.
The CC-IS cell culture isolator works on creating autologous cell and gene therapies, that include the activation and transduction process of non-infectious viruses, viral carriers, which could turn infectious or overexpressed.
Speaking about the range, Tema Sinergie wrote: "The process chamber was developed following the mandatory needs of the user, and integrates further devices for the execution of specific processes, among which we can count two incubators, a refrigerator, a centrifuge, a Flexicon peristaltical pump, two rapid transfer Port Dpte, a Sart Port and an electronic microscope. Like all the company's aseptic isolators, CC-IS is also equipped with the HYPER system for an effective and efficient bio-decontamination process, designed to guarantee a level of log-6 sterility."
Like all the company's aseptic isolators, CC-IS is also equipped with the HYPER system for an effective and efficient bio-decontamination process
The CC-IS isolator was designed to allow for a maximum fluidity and flexibility of the customer’s work process. That’s why it’s been equipped with two different pre-chambers, a larger and a smaller one positioned at the lower level of the process enclosure, and equipped with a pneumatic lifting system for the materials to be risen to the level of the work surface.
The characteristics of both the isolator and its specific process equipment are conceived to grant for safety and straightforwardness, and are controlled by 19″ HMI touch, from which it is possible to constantly verify all the work parameters.
This isolator system comes from a custom project for the preparation of CAR-T cell therapies, requiring a complex process of cell engineering, according to rigid quality control protocols. It is now safe to say that isolators represent the ideal setting for the development of cell and gene therapies, allowing to avoid for contamination of both the material and the work environment.
It is also necessary to yet favour the operator, recreating a real laboratory inside the machine, that needs to be actually performing. Thus, as in the case of the CC-IS, the isolators are designed to grant the highest level of asepsis while offering maximum ergonomics to the operator, as well as hosting all the necessary and functional options to achieve an optimal result for the customer.
A key role for the success of the project was held by the company's Technical Sales Team, which fully supported the customer from very beginning, through dedicated engineering advice leading first to the development of the process itself, then to the proper production of the isolator.