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        <title>Quality and microbiological controls</title>
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        <description>The FaBioCell cell factory terminated its operations as of July 2025.

FaBioCell Area

Quality and microbiological controls

The Quality Control is the part of the GMP related to the sampling and testing procedures that ensure that the necessary and relevant tests have been carried out and that the product is released, for the use for which it is intended, only after its quality has been verified.</description>
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        <description>The FaBioCell cell factory terminated its operations as of July 2025.

FaBioCell Area

Cell Products

FaBioCell can produce all types of cellular drugs, such as:
Dendritic cells generated by CD14 + monocytes;T lymphocytes;Natural Killer cells;Stem cells;</description>
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        <title>GMP Production / Cell manipulation / ATMP</title>
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        <description>The FaBioCell cell factory terminated its operations as of July 2025.

FaBioCell Area

GMP Production / Cell manipulation / ATMP

Working in a “GMP facilities” or “Cell Factory” became mandatory following the issuance of the European directive 2001/20 which established that the production of experimental drugs must comply with the Good Manufacturing Practices, normally indicated with the English acronym GMP (Good Manufacturing Practice). GMPs are the European guidelines whose application is mand…</description>
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        <title>Research</title>
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        <description>The FaBioCell cell factory terminated its operations as of July 2025.

FaBioCell Area

Research

GENEVAX Project

[Loghi]




In the context of the POR FESR, Key Enabling Technologies (KETs) calls, the FaBioCell cell factory has recently received a loan from</description>
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        <description>The FaBioCell cell factory terminated its operations as of July 2025.</description>
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Access regulation to the Service 

Service requests 

Brochure 

Reserved section 

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 Areas 

 Cytometry 

 EPR 

 FaBioCell cell factory 

GMP Production / Cell manipulation / ATMP The Quality System in pharmaceutical contextQuality and microbiological controlsCell productsClinical trialsResearchStaffService request
 NMR &amp; MRI 

 Microscopy 

 Proteomics 

 Next Generation Sequencing 

 Scientific Computing

----------

 Services and tools in collaboration</description>
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        <dc:date>2025-08-26T18:25:11+02:00</dc:date>
        <title>The Quality System in the pharmaceutical context</title>
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        <description>The FaBioCell cell factory terminated its operations as of July 2025.

FaBioCell Area

The Quality System in the pharmaceutical context

Since its early stages, the development of a drug must adhere to an appropriate Quality System (SQ) aimed at producing</description>
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        <title>Clinical Trials</title>
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        <description>The FaBioCell cell factory terminated its operations as of July 2025.

FaBioCell Area

Clinical Trials

Clinical studies in progress
Phase I clinical study of adoptive immunotherapy, characterized by the infusion of autologous Natural Killer (NK) cells, after enrichment and expansion, in patients with acute lymphoblastic leukemia (LLA) Philadelphia (Ph)+ in complete haematological remission but with persistent recurrent minimal residual disease (in collaboration with the Policlinico Umberto I, S…</description>
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        <title>Staff and contacts</title>
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        <description>The FaBioCell cell factory terminated its operations as of July 2025.

FaBioCell Area

Staff and contacts

Qualified Person 

Luciano Castiello  

☎ +39 06 4990 6080

Quality Assurance 

Luciano Castiello

Production 

Laura Santodonato, Enrica Montefiore

Quality Controls</description>
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        <title>FaBioCell Cell factory</title>
        <link>https://corefacilities.iss.it/dw/doku.php?id=en:recycler:20250823-fabiocell:start</link>
        <description>The FaBioCell cell factory terminated its operations as of July 2025.

Area

FaBioCell Cell factory

General presentation






FaBioCell is a “cell factory”, namely a pharmaceutical factory authorized to produce drugs for cell therapies. Cell therapies, together with gene therapy drugs and tissue engineering products, constitute the family of Advanced Therapy Medicinal Products or ATMP.</description>
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