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en:recycler:20250823-fabiocell:start [2018/08/03 14:08]
Gianluca Frustagli created 		en:recycler:20250823-fabiocell:start [2025/08/26 18:24] (current)
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 +<WRAP center round important 60%>
 +**The FaBioCell cell factory __terminated__ its operations as of July 2025.**
 +</​WRAP>​
  
 +**Area**
 +
 +====== FaBioCell Cell factory ======
 +
 +==== General presentation ====
 +
 +\\
 +
 +{{:​recycler:​20250823-fabiocell:​logo.png?​150 |}}
 +
 +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.
 +
 +FaBioCell was founded with the aim of encouraging the process of transferring to the clinic the results of research conducted in the field of tumor immunotherapy,​ not only in ISS but also in collaboration with other research and clinical centers, taking into account the growing attention to the promising clinical use of personalized cellular drugs.
 +
 +According to the Directive 2001/20/EC (implemented with Legislative Decree n° 211 of 2003, which came into force on 01/​01/​2004),​ Drugs for Advanced Therapies must be produced in compliance with the Good Standards Manufacture,​ GMP, in facilities equivalent to "​pharmaceutical workshops"​ subject to the authorization procedure by the Italian Medicines Agency. \\
 +In 2011, FaBioCell obtained the authorization to produce cell therapy drugs (n° aM 30/2011), that was reconfirmed in 2014 (n° aM 139/​2014). ​
 +
 +\\
 +
 +{{ :​recycler:​20250823-fabiocell:​lab.png |}}
 +
 +\\
 +
 +=== To ask for the service: ===
 +
 +  - preliminary contact the [[staff|FaBioCell cell factory area staff]];
 +  - fill out the online form '​**[[richiesta|Service Request]]**'​ briefly illustrating the scientific problem;
 +  - plan a meeting with the cell factory staff to discuss methods, costs, timing etc.
 +
 +/* > FIXME **To be revised.**\\ //(remove this paragraph once finished)// */