Cellular Therapy protocols have to guarantee rigorous criteria concerning the cellular product definition and quality. Indeed, clinical grade productions need strict culture conditions with the use of good manufacturing practice (GMP) reagents (culture media, cytokines…), in a controlled environment and according to production process validated and well defined. Those criteria refer to specifications that are generally not considered by experimental studies.
Thus, the core facility named “Plate-forme DTC” (Development and Clinical Transfer) improves the transfer of cellular therapy research protocols towards clinical applications through two activities
- The first one upgrades research protocols to a “clinical level”. This activity is managed in collaboration with the Cellular Therapy Unit based in Nantes hospital and mainly consists in studying and validating the use of GMP products.
- The second one is a service for public laboratories. The aim of this activity is to make potential transfer easier from the beginning of a research protocol. It consists in providing human peripheral blood cells (especially monocytes and lymphocytes) purified in technical and quality conditions close to those used in clinical protocols.
The “plate-forme DTC” provides technological supports within a context of traceability and quality insurance according to ISO 9001 norm.
- FACSCalibur Flow Cytometer
- Counterflow Centrifugal Elutriation system
- Cell Counting Instrument
- Overpressured and filtered air in cell culture room
- Dedicated and qualified equipment
- Quality Insurance S.O.P (reproducibility – traceability)
Service provision to academic players.