San Raffaele Telethon Institute for Gene Therapy

GLP Test Facility

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manager

Paola Albertini

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Several gene therapy clinical trials using gene-modified hematopoietic stem cells have shown therapeutic efficacy in multiple disease areas. As this therapeutic strategy is applied to an increasing number of diseases, rigorous studies in appropriate non-clinical models are needed to assess the risk/benefit ratio and fulfil the requirements for clinical trial applications and future market approvals.

Good Laboratory Practice (GLP) is a quality system related to the organizational processes and conditions under which non-clinical health safety studies are planned, performed, monitored, recorded, reported and archived (D.Lgs.50, 2 marzo 2007:G.U.86, 16 aprile 2007 and OECD Principles of Good Laboratory Practice N.1, as revised in 1997, ENV/MC/CHEM(98)17). GLP regulations and guidelines for the conduct of preclinical testing ensure the quality and integrity of data submitted in support to the development of new treatments, foster mutual acceptance of data in the international community, serves to minimise redundant testing, minimize animal use and maximise protection of human health.

San Raffaele TIGET Institute has established GLP compliant Test Facility within IRCCS Ospedale San Raffaele to perform studies in compliance with GLP principles and data integrity to support Gene Therapy Medicinal Products (GTMPs) development.

Facility

GLP Facility include:

  • two BSL2 laboratories, one dedicated to the cellular activities and one where are run molecular biology assays;
  •  BSL2 animal rooms in SPF animal facilities;
  • one necropsy room in SPF animal facilities;
  • one archive;
  • one facility dedicated to Flow Cytometry;
  • one Histopathology laboratory;
  • one Pathology Laboratory;
  • QA; Study Directors and Management offices.

Organisation

SR-TIGET GLP Test facilities include full-time GLP trained staff with technical and scientific skills organized as follows: management; quality assurance; SOP administrator; archivists; study directors; pathologists; designated veterinarian; Technicians.

In addition, scientific leaders of specific lines of research are also part of this organization and give their scientific support and advice as consultants.