Cellular Manufacturing and GMP Rooms
The facilities of the Cell Production Unit and GMP Rooms are integrated into a network of 5 Medicinal Product Manufacturers for Advanced Therapies authorized by the Spanish Agency of Medicines and Medical Devices (AEMPS) within the framework of the Andalusian Network for the Design and Translation of Therapies (RAdytTA). Located on the seventh floor of Pavilion A at the University Regional Hospital of Malaga, these facilities meet the required quality and safety standards for aseptic drug manufacturing
Services
- Isolation of mesenchymal stem cells derived from adipose tissue and in vitro expansion until obtaining the dose assigned according to the protocol and its later packaging
- Quality controls for cell therapy drugs validated according to European pharmacopeia: sterility, endotoxins, mycoplasma, potency, and phenotype)
- Methodological, scientific, and technical advising on cell therapy clinical trials
Equipment
The Unit has three authorized rooms for aseptic manufacturing of Advanced Therapy Medicinal Products (ATMPs) according to Good Manufacturing Practices (GMP) standards
The Unit is authorized by the Spanish Agency of Medicines and Medical Devices to manufacture cell therapy medicinal products based on adipose tissue-derived mesenchymal stem cells (CMMTAd) for autologous or allogeneic use. It is also authorized for conducting the corresponding quality controls according to the European Pharmacopoeia (Ph. Eur). In this Unit, medicinal products based on CMMTAd are manufactured for use in clinical trials for cell therapy in pathologies that lack or do not respond adequately to conventional treatments, such as Amyotrophic Lateral Sclerosis (ALS), structural Fecal Incontinence, or Acute Cerebral Infarction or Stroke
