Cell Production and GMP Rooms

IBIMA has three GMP (Good Manufacturing Practices) rooms in Pavilion A of the Regional University Hospital (RUH) of Malaga where clinical trials are carried out with cell therapy medicinal products. These are facilities that meet specific parameters for manufacturing based on stem cells for therapeutic purposes and which are subject to strict safety requirements verified by the Spanish Agency for Medicines and Health Products (AEMPS), the entity responsible for providing final accreditation  for operation. Manufacturing operations authorized by AEMPS, to date, are isolation and expansion of mesenchymal stem cells derived from adipose tissue.

After inspection and authorization by the AEMPS, these rooms house new clinical trials in cell therapy for diseases that do not have or do not respond adequately to conventional treatments such as Amyotrophic Lateral Sclerosis (ALS), or structural Fecal incontinence; all funded projects and currently underway at the RUH.

The facilities cover an area of 92 m2 on the seventh floor of Pavilion A of HRU Malaga. Both the infrastructure and the team that supports the CPU, foster different lines of R&D in Cell Therapy and cater to the different medical-surgical disciplines of the Andalusian Public Health Service (SSPA) hospitals and other partner institutions wishing to implement Cell Therapy and Regenerative Medicine as treatment. These facilities are isolated and expand “ex vivo” cells to be used in humans, either in the clinical research phase or as treatment. These clean rooms are integrated into a network of 12 Cell Production units within Andalusia in eight centers in the provinces of Cordoba, Granada, Malaga and Seville. They are structured within the framework of the Andalusian Initiative in Advanced Therapies (IATA) sponsored by the Department of Health, in collaboration with the Department of Innovation, Science and Enterprise, which aims to promote the development and application in clinical practice of results of research in the field of cell therapy, gene therapy and nanomedicine.

  • Objectives
  • Services
  • Members

The main objective is the isolation and expansion of mesenchymal stem cells for use in humans, either in clinical investigation or as treatment, ensuring that they meet all safety requirements and quality standards established in the GMP of the AEMPS.

Additionally, other objectives include:

  • Advising on the identification of new cell therapy
  • Development of new production protocols for cell therapy
  • Training in the development of cell therapy clinical trials
  • Continuous improvement of the services offered and incorporation of new services.
  • Isolation of adipose tissue-derived mesenchymal stem cells, in vitro expansion to assigned dose according to protocol and subsequent packaging.
  • Quality Controls for Cell Therapy Trials:
  • Immunophenotyping of cells using flow cytometry.
  • Detection of mycoplasma DNA in cell culture supernatants and biological fluids, according to the European Pharmacopoeia:
    Species  Detection limit LOD95[CFU/ml]
    Acholeplasma laidlawiiMycoplasma fermentansMycoplasma hyorhinisMycoplasma oraleMycoplasma synoviaeMycoplasma pneumoniaeMycoplasma argininiMycoplasma gallisepticumSpiroplasma citri

    ≤ 2.5

    ≤ 2.5

    ≤ 2.5

    ≤ 10

    ≤ 10

    ≤ 10

    ≤ 10

    ≤ 10

    ≤ 10

  • Identification of endotoxins in cell culture media and reagents, according to European Pharmacopoeia.
  • Differentiation of mesenchymal cells into osteoblasts and adipocytes.
  • Gram stains and calcofluor cell cultures
  • Growth promotion testing, according to the European Pharmacopoeia
  • Microbiological control of environment and facilities with ISO classification :
    • volumetric airflow;
    • Sedimentation plates;
    • Surface contact.
  • Qualification of thermal systems: refrigerators, freezers, stoves, etc …
    • Methodological, scientific and technical advice on cell therapy clinical trials:
    • Management, evaluation and assessment of clinical trial documentation.
    • Preparation of clinical trial documentation: advice on the development of research protocols and manuals; preparation of investigational medicinal product dossiers (IMPD) for clinical trials on cell therapy developed in our unit.
    • Support for authorization requests and/or responses to requests for clarification to the relevant agencies (Ethics Committees, AEMPS …).
  • Training in Introduction to Cell Therapy
  • Antonio Rodriguez Acosta
  • Laura Leyva Fernandez
  • María Victoria Rodríguez-Acosta
  • Rafael Maldonado Sánchez
Cell Production and GMP Rooms