The cell and gene therapy isolator range from Tema Sinergie is developed for GMP-regulated handling and production of advanced therapy medicinal products. These systems create a Grade A (ISO 5) controlled environment that supports sensitive cell and gene manipulation activities for both clinical manufacturing and research.
Compared with conventional biosafety cabinets and cleanrooms, the isolators provide a higher level of protection against microbial and cross contamination. Unidirectional airflow and integrated biodecontamination support a robust, controlled process environment. The systems can be configured to integrate dedicated process equipment such as incubators, centrifuges, and digital microscopy, aligned with specific workflow needs.
Typical applications include autologous and allogeneic therapy processes, cell activation and transduction, viral vector handling, and gene therapy manufacturing. The systems are designed to support compliance with Annex 1, EU GMP guidance, cGMP principles, GAMP 5, and FDA 21 CFR Part 11.
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