
Along with the continuing advances in cell and gene therapy within modern biomedical research, the demand for advanced cell therapy treatments is increasing. The corresponding manufacturing processes rely on stringent cGMP needs for an aseptic environment to safely prepare and process sterile therapy products with highest integrity including CAR-T cell immunotherapy and Platelet-rich plasma therapy treatments or mesenchymal stem cells. With respect to the personalized nature of advanced cell therapies, several aspects of preparation and production processes are critical to the treatment’s quality and safety matters. Hence, the processes need to be carried out in a safe aseptic environment, while isolator technology provides the highest guarantee of process sterility in a controlled grade A environment. Isolator systems allow the integration of various laboratory equipment required to perform the processes in each of the advanced therapy preparation steps including centrifuges, incubators, refrigerators, gene modification devices and devices for both upstream and downstream cell processing. Ultimately, the closed isolator system establishes a fully validated process solution for both clinical lab-scale applications as well as product manufacturing in cell therapy including the possibility of implementing the final preparation filling in vials, syringes and IV Bags.

