Advanced Therapies Platform

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La Cell Production and Tissue Engineering Unit (UPCIT) of the Virgen de las Nieves University Hospital in Granada was created in 2008 in the former facilities of the Bank of cell lines of Andalusia. In December 2009, it became the first GMP laboratory of the Andalusian Health Service to obtain accreditation from the Spanish Agency for Medicines and Health Products (AEMPS). It is currently authorized for the manufacture of several advanced therapy medicines (cellular therapy and tissue engineering therapy) that are used in patients of the Andalusian Public Health System through clinical trials or compassionate use. From its beginnings (2008) to June 2014, it was directed by Dr. Manuel de la Rosa Fraile and from July 2014 to the present by Dr. Salvador Arias Santiago.

The UPCIT has the following objectives:

Produce Advanced Therapies medicines according to European Union Good Manufacturing Practices (GMP).
Carry out quality controls of medicines according to the European Pharmacopoeia.
Continuous improvement of processes, preclinical research, training and galenic development for scaling up to GMP production.

To this end, it has facilities specially designed and built for the production of advanced therapy medicines and tissue engineering to carry out clinical trials in humans or compassionate use, for which reason its activity is regulated by the Good Manufacturing Practices for medicines of the European Union. According to these good manufacturing standards (NCF-GMP) and the Directive that applies, the manufacture of sterile medicines is subject to special requirements to minimize the risks of microbiological, particle, virus and pyrogen contamination.

The UPCIT has two GMP clean rooms fully equipped and authorized by the Spanish Agency for Medicines and Health Products (AEMPS) for the production of:

- Allogeneic adult mesenchymal stem cells from expanded adipose tissue.

- Allogeneic adult limbal stem cells from expanded sclerocorneal limbus combined with allogeneic differentiated adult keratocytes from expanded cornea in biological matrix.

- Sheets of differentiated autologous adult skin keratinocytes and fibroblasts expanded in biological matrix.

These cell- or tissue-based medicines are currently being used in patients through clinical trials, compassionate use, or consolidated use. Quality is of particular importance and this manufacture must strictly follow preparation and quality control methods according to carefully established and validated procedures.

The Spanish Agency for Medicines and Health Products carries out a face-to-face inspection of the UPCIT every three years, the last one having been carried out on April 6 and 7, 2022.

The Cellular Production and Tissue Engineering Unit of the Hospital Virgen de las Nieves in Granada, is part of the Network of laboratories manufacturing Advanced Therapy medicines of the Andalusian Public Health System, and carries out its activity under the coordination of the RAdytTA. Said coordination is exercised by virtue of the resolution of April 9, 2019, of the General Secretariat for Research, Development and Innovation of the Ministry of Health and Families, in which it constitutes the RAdytTA: Andalusian Network of Design and Translation of Therapies advanced.

In addition, with the accreditation of the Biosanitary Research Institute ibs.GRANADA by the Carlos III Health Institute, the Cell Production and Tissue Engineering Unit is incorporated as a platform of the Institute.

It is located on the 4th Floor of the Government Building. Virgen de las Nieves University Hospital, with an area of 306 m²

Portfolio of Services for SSPA (Public Health System of Andalusia)

Clinical trials authorized by the AEMPS

Clinical trials pending authorization by the AEMPS

Quality controls

Quality controls are carried out at the UPCIT or facilities of the Virgen de las Nieves University Hospital: sterility, determination of Mycoplasma, genetic stability, phenotype, cell differentiation assays, virus culture, endotoxins, cell viability assays...

Other activities

Advise researchers on translation and scaling of advanced therapy drugs.
Collaboration in preclinical research projects aimed at the development or improvement of advanced therapy drugs.
Cell culture of differences cell lines for healthcare or research uses.

The organizational chart of the Cell Production and Tissue Engineering Unit (UPCIT) It is currently integrated by the following figures: