The refurbishment involved the first and third floors of an existing building located in an industrial area in Bresso and part of the Zambon Science Park. The intervention involved the construction of new laboratories and related support spaces, equipped with the following characteristics:
- the production of starting materials (cell banks), intermediates / reagents and sterile medicinal preparations for gene and cell therapy as defined in the ATMP guidelines (guidelines for medicinal products derived from advanced therapies) and in Annex II of the European EU GMP guidelines (guidelines for good factory practices);
- the manipulation in a confined environment of GMOs, genetically modified microorganisms belonging to biosafety class 2-BL2 and class 3 (BL3); the latter carried out in a dedicated area, controlled and separated from class 2, according to Legislative Decree n ° 206 of 12 April 2001;
- the possibility (in a dedicated and controlled area) to hold and manipulate radon;
- flexibility, since the general layout and conditioning systems allow for simultaneous activities on batches of different preparations for both gene therapy and cell therapy;
- the design and validation in accordance with the international GMP guidelines – good manufacturing standards (Annex II EU GMP guideline) and in a manner that will allow the introduction of any new technologies in the future in terms of new equipment and / or new types of Research.
The main functions are:
- gene therapy area with GMP layout and procedures, divided into two sectors that can be independent (to possibly also perform cell therapy);
- laboratory area (Quality Control (QC) and Research & Development);
- storage area (primary materials and preparations);
- areas for technical functions;
- office areas to support the laboratories.