Transgene Immunotherapy R&D and Production System

A case study of Comecer ATMP solutions

Transgene - Immunotherapy R&D and Production System

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Customer

Transgene S.A. | Strasbourg, France

Customer Challenge

Cultivation of Therapeutics Cancer Vaccines and Oncolytic Viruses in a contained environment.

Performance Requirements – Transgene

  • GMP-grade isolation technology
  • 200 Liter of Incubation Space (CO2, RH and T monitored)
  • Large working space able to accommodate several process tools

Solution Highlights Transgene

Comecer installed a sterile workstation for cell culture, in the 2-working-chambers configuration, customized for the needs of Transgene’s process. It includes centrifuges, refrigerators, a culture oven, and sampling access.

Included in the installation there is a Comecer FlexycultTM Incubation System. It is used to handle cultivation and expansion of starting materials and intermediate products needed for the subsequent GMP aseptic production of the biological drugs.

FlexyCultTM is a multiple single-batch incubation modules system connected to a shared utilities docking station. Several incubators can be located in the same environment without risk of possible cross-contamination, as two incubators are not allowed to be open at the same time, and there are no external contacts. Safety is guaranteed, with maximum flexibility and space saving configuration.

Comecer customized setup and parameters for specific conditions, to adapt the cultivation environment to the actual process needs.

A dedicated, specifically-designed solution for Grade A air/CO2 circulation, coupled with a wall heating system, allows perfect distribution of the temperature and CO2 inside the culturing environment.

Centralized control of all the relevant parameters takes place through of an embedded motherboard and a supervisory system. Alarms are foreseen to advise for out-of-range parameters.

地点: Strasbourg, France

类别: ATMP

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