Cell Factory

Rigenerand wants to be a partner to develop and produce cell and gene therapy to address unmet clinical needs in compliance with highest regulatory standards

  • The cell factory has a wide controlled contamination area (clean room), a quality control laboratory, a GMP-controlled warehouse and a cryogenic room for cell banking

 

  • The clean rooms occupy 450 m² of classified area with three BSL2 Class B rooms,  two BSL3 Class B rooms, one Class C warehouse, dedicated access corridors and a Class D transfer material zone

 

  • The quality control laboratory is equipped to perform microbiologic tests to monitor the classified rooms and to execute quality and safety controls on intermediate and final products

 

  • The cryogenic room is equipped with N2 dewars for storage and device for controlled freezing

 

  • The facility can produce both somatic and gene modified cell therapies

 

  • The personnel of the cell factory is trained to offer a high level of qualified expertise from pre-clinical studies to scale-up in product manufactoring

 

  • The facilities and the qualified team enable technology transfer from Partners willing to treat patients with cell & gene therapy products

Rigenerand: a partner for ATMPs development