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BioPharma >> Comprehensive Cell and Gene Therapy Testing Capabilities >> Accreditations

Accredited Laboratory

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AIFA authorization to perform biological, microbiological, chemical-physical and chemical quality control tests in compliance with Good Manufacturing Practices (GMP).

Download GMP Authorization (PDF) | Download GMP Certificate (PDF)

All facilities are approved to facilitate testing Genetically Modified Microorganisms (GMMO) up to Level 2 and host molecular and cell biology tests, as well as biochemistry analyses. Several types GMMOs class 1 and already authorized GMMO class 2 are daily handled in our laboratories.

Eurofins BioPharma Product Testing Italy provides timely handling of further class 2 GMMP approval requests.

Additional capacity has been significantly increased in 2021, building new GMP facilities able to fulfil BSL2 requirements, with about an additional 1000 m2 of net BSL2 GMP fully operational laboratory space.

To date, this represents one of the biggest BSL2 facilities among the Eurofins BioPharma Product Testing global network.

These facilities include several testing rooms, with negative pressure cascades and H14 HEPA filtration, supporting a wide range of testing. Thanks to the fully dedicated GMP and GMMO BSL2 facilities, we can support biopharmaceutical companies throughout the biologic lifecycle from analytical method development to marketed product release analysis with drastically increased capacity.

 

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