San Raffaele Telethon Institute for Gene Therapy
SR-Tiget Clinical Lab
The SR-Tiget Clinical Lab (TCL) is a certified laboratory that runs tests required for clinical trial endpoints following GCLP (Good Clinical Laboratory Practices) requirements. The TCL performs analytical laboratory activities on samples derived from patients that underwent Advanced Therapies Medicinal Products (ATMP) treatment. In addition, the TCL performs specific lab studies on patients enrolled in other non-interventional SR-Tiget research protocols. The TCL is a self-certified Phase I Center recognized by AIFA and works under GCLP, GCP (Good Clinical Practices), and following GLP (Good Laboratory Practices) standards when applies, certified with an ISO 9001 quality system. TCL personnel is specialized in advanced analyses not routinely performed by diagnostic clinical labs.
Activities
The TCL performs key analyses during the Phase I/II and Phase III Clinical Trial for ATMP, providing to the Sponsor (Internal or External) results that are fundamental for the application for further clinical development or commercialization of Medicinal Products to Medicinal Agencies (EMA, FDA), thus contributing to the final step of the Bench-To-Bed transition of Scientific Knowledge.
Non-exhaustive list of tests performed by the TCL:
- PB-BM processing and subpopulation purification
- BM – Colony Forming Units (CFU)
- VCN from subpopulations or CFU
- Immune response to transgene
- T cell proliferation assay
- Transgene expression
- Transgene enzymatic activity evaluation
- TCR repertoire evaluation
- Elispot
Eleonora Cicoria
Quality assurance
Laura Castagnaro
Quality manager
Claudia Sartirana
Technician
Federica Salerio
Senior Technician
Clelia Pierini
Technician
Ilaria Monti
Lab study manager junior
Stefania Monteverde
Laboratory manager
Simona Miglietta
Lab study manager
Giulia Loffredo
Technician
Stefania Giannelli
Lab study manager
Fabiola De Mattia
Lab study manager
Sara Mazza
Research assistant
Giulia Rota
Research assistant