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Customer

Undisclosed Cell Factory USA

Customer Challenge

Customer needed to support a program of cell cultivation aimed at immunotherapy for cancer treatment, to be performed in bags according to its proprietary protocol.

Customer was particularly interested in the complete segregation of the cell bags during incubation, being an autologous therapy, and in performing the whole manipulation process in a completely isolated environment.

 Performance Requirements

• Isolator integrated with all the necessary devices and equipment (centrifuge, fridge, etc.) to allow for carrying out the whole cell manipulation process inside.
• Multiple Incubators to segregate each patient’s cultivation bags, with an internal volume and arrangement to contain the number of bags required by the process.
• Class A sterile incubators able to maintain complete isolation from the external lab and to directly and tightly connect to the isolator internals, for further opening and cell manipulation.
• Isolator and modular incubators to be decontaminated by VPHP through a completely automatic, reproducible, validated and time-saving process.

Solution Highlights

Comecer studied, designed and manufactured a FlexyCult™ system (9 incubators) and a dedicated Isolator with unique features and customized components:

• Docking station to house 9 incubators and to manage the desired internal conditions of all incubators
• HEPA Filters positioned inside each incubator, one in the inlet and one in the outlet, to guarantee air cleanliness
• Each incubator provides 7 sliding removable trays to house up to 14 cell bags (customer requirement) and to act as a working plane during the manipulation phase inside the isolator
• Dedicated lifter & trolley for incubator withdrawal from the docking station and transport to the isolator
• Customized alfa and beta RTP ports, placed respectively on the isolator and incubator side, to allow for tight connection and to always maintain sterility inside both environments
• Dedicated VPHP generator connected to the docking station for decontamination of a maximum of 3 incubators at once, while others still continue to run.