Clinical- Scale Manufacturing and Development

Centralisation of many quality control services

The experience gained by the Coordination Unit of the Andalusian Network for the design and translation of Advanced Therapies as a consequence of its participation in the development of more than ten medicinal products in research has led to the centralisation of many quality control services at the reference laboratory at the Virgen de las Nieves University Hospital. This move has also led to greater efficiency.

The above mentioned laboratory, which belongs to the Andalusian Public Health System, has been authorised by the Spanish Agency of Medicines and Medicinal Devices to manufacture advanced therapy medicinal products as well as to act as reference centre to carry out required quality controls in the manufacture of this type of products.

The quality control trials for which our reference laboratory is authorized are the following: sterility and control of microorganisms in cell products, endotoxin analysis, mycoplasma identification, phenotype analysis by flow cytometry, viability analysis, cytogenetic analysis, analysis of the presence of adventitious viruses and finger printing among others. All these trials are on guaranteeing the quality of the manufactured medicinal products in research. Therefore, our laboratory is equipped with the full range of resources needed to carry out these various analyses.

All these services are carried out in accordance with the standards set out in the European Union guidelines for good manufacturing practice and European Pharmacopoeia, and are performed by highly qualified experts.

Product development and manufacturing

Our network of GMP laboratories has vast experience in the manufacturing of advanced therapy medicinal products ranging from cell therapy products, tissue engineering products to gene therapy for the use of the society at large.

The variety of GMP laboratories available allows for the development of various kinds of products. The logistics of the distribution of the various medicinal products in research for patient use are facilitated by the fact that many GMP laboratories are located at hospital sites. Otherwise a simple authorised distribution system is in place to serve those hospitals which might become involved in the treatment of patients.

We have highly educated professionals with extensive experience in the advanced therapy area. Consequently, we can facilitate, to a large extent, the development of the advanced therapy medicinal product of interest.