Hospitals

Fundación Investigación Biomédica (Biomedical Research Foundation) (FIB):

• Preparation of the CTD Dossier of Gene Therapy Medicinal Product to request the non-industrial authorization for use from AEMPS.
• Feasibility study and strategic Action Plan for the Fundación de Investigación Biosanitaria (Biosanitary Research Foundation) of the Hospital Infantil Universitario Niño Jesús.

Gene and Cell Therapy Manufacturing Unit: 

• Preparation of the CTD Dossier of Gene Therapy Medicinal Product.
• Outsourcing of the tasks of GMP Quality Assurance in the Gene and Cell Therapy Unit.
• GMP-compliant audits of the Gene and Cell Therapy Unit.
• Consulting services on GMP Quality Assurance: Deviation review and closure. Batch records review.
• Specialized training in GMP Standards for Advanced Therapy Medicinal Products (ATMPs).

Hospital Pharmacy Service HIUNJ:

• Preparation of the CTD Dossier of Gene Therapy Medicinal Product.
• Specialized training in the access to and clothing for classified areas (cleanrooms) of the Hospital Pharmacy Service.

ATMP Manufacturing Unit of the Children’s Hemato-Oncology Service:

• Implementation of GMP in the manufacturing unit of CARTs.

Children’s Hemato-Oncology Service:

• Preparation of the IMP Dossier and Research Protocol (IB) for Clinical Trials for an Advanced Therapy Medicinal Product (ATMP).

Fundación para la Investigación Biomédica (Biomedical Research Foundation):

• Administrative tasks and monitoring of the Clinical Trial in Phase IIa to verify the safety of the treatment of Nonrevascularizable Critical Ischemia of the Lower Limbs using mesenchymal stem cells.

Cell Therapy Unit of the Hematology Service: 

• Scientific advice on AEMPS: advice on facility design and GMP compliance.
• Implementation of GMP regulations in the new Cell Therapy Unit for the manufacturing of CARTs and TILs.

Cell Therapy Unit of the Blood and Tissue Bank of Cantabria:

• Technical Advice, Evaluation and Engineering Selection.
• Scientific advice on AEMPS on facility design and GMP compliance.
• Implementation of GMP regulations in the Cell Therapy Unit for the manufacturing of ATMP.
• GMP certificate issued by AEMPS.

Institut d’Investigació Biomèdica (Biomedical Research Institute) Sant Pau (IIBSP):

• Implementation of GMP regulations in the Therapy Unit for the manufacturing of CARTs.
• GMP certificate issued by AEMPS.
• Specialized training in GMP for the Development of Advanced Therapy Medicinal Products (ATMPs).
• Audit in compliance with GMP regulations of the Gene and Cell Therapy Unit.

Cell Manufacturing Unit:

• Advising in GMP Quality Assurance: improvement of Quality System processes of the Cell Manufacturing Unit of the Cancer Immunotherapy Program.

General Foundation of the University of Salamanca. Castellano Leonesa Foundation for Hematology and Hemotherapy:

• Administrative tasks and monitoring of the Phase I/II Clinical Trial for the treatment of osteonecrosis of the femoral head through the administration of autologous mesenchymal cells. EudraCT: 2011-005258-70.
• Administrative tasks and monitoring of the Phase I/II Clinical Trial for the treatment of cytopenia after allo-HSCT through the administration of a sequential infusion of allogeneic mesenchymal cells. EudraCT: 2013-000534-35.
• Administrative tasks and monitoring of the Phase I/II Clinical Trial for the treatment of postoperative air leak after lung resection in high risk patients through the administration of mesenchymal autologous cells. EudraCT: 2013-00535-27.

Cell Manufacturing Unit of the Hematology and Hemotherapy Service: 

• Specialized training in Risk Management and Trend Evaluation in GMP contexts for Advanced Therapy Medicinal Products (ATMPs).

Cell Manufacturing Unit of the Neuroscience Service:

• Implementation of GMP regulations in the Cell Manufacturing Unit of the Neuroscience Cancer Immunotherapy Program (UINC). 
• GMP certificate issued by AEMPS.

• Advising and training in Management of OOS Results in GMP contexts and Regulatory Review of ATMP Processes.
• Audit of GMP Quality System for the manufacturing of Advanced Therapy Medicinal Products (ATMPs).
• Specialized training in GMP for Advanced Therapy Medicinal Products (ATMPs).
• Advice on the validation of GMP processes.

• Advising and training in Management of OOS Results in GMP contexts and Regulatory Review of ATMP Processes.
• Audit of GMP Quality System for the manufacturing of Advanced Therapy Medicinal Products (ATMPs).
• Specialized training in GMP for Advanced Therapy Medicinal Products (ATMPs).
• Advice on the validation of GMP processes.

La Fe Health Research Institute (IIS La Fe):

• ATMPs Pre-clinical and Clinical Validation Platform: Technical advice on GMP-certified facilities. Feasibility Study and Business Model for PLECTRA (PLataforma prEclíniCa de TeRapias Avanzadas – Advanced Therapies Pre-clinical Platform).
• Specialized training in the Development of Advanced Therapy Medicinal Products (ATMPs).

Cell Therapy Unit: 

• Scientific advice on AEMPS: advising on the design of the clinical trial, pre-clinical and clinical studies, and the design of the quality module for the preparation of the IMPD.
• Implementation of GMP regulations in the Cell Therapy Unit.

• Diagnosis of the current situation of facilities to adapt them for the manufacturing of Cell Therapy Medicines.
• Scientific advice on AEMPS: advising on the design of a clinical trial, pre-clinical and clinical studies, and the design of the quality module for the preparation of the IMPD for an Advanced Therapy Medicinal Product (ATMP).
• Implementation of GMP Correct Manufacturing Regulations for the Advanced Therapies Unit of HUF.

• Specialized training in the access to and clothing for classified areas (cleanrooms) of the Hospital Pharmacy Service.

• Preparation of the IMP Dossier, Research Protocol (IB) and Clinical Trial Protocol for an Advanced Therapy Medicinal Product (ATMP).

• Feasibility Study and Plan for the construction project, commissioning process and GMP certification of a facility for the manufacturing of cell therapy medicinal products.
• Financial Advising (Installation and Maintenance of a Cleanroom) and Task Timeline. 

• Preparation of the IMP Dossier, Research Protocol (IB) and Clinical Trial Protocol for an Advanced Therapy Medicinal Product (ATMP).

Hematopoietic Transplantation and Cell Therapy Manufacturing Unit: 

• Implementation of GMP regulations in the Cell Therapy Unit. GMP certificate issued by AEMPS.
• Specialized training in GMP for Advanced Therapy Medicinal Products (ATMPs).

Fundación para la Formación e Investigación Sanitarias (Foundation for Health Research and Training) of the Murcia region (FFIS):

• Monitoring, administrative tasks and data base management of “Phase I/II Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis.” EudraCT: 2006-003096-12.
• Monitoring of Phase I/II Clinical Trial on “Using Amniotic Membrane for the Skin Replacement in Big Wounds.” EudraCT: 2011-004395-11.
• Scientific advice on AEMPS: advice on the design of the clinical trial, pre-clinical and clinical studies and design of the quality module for the preparation of an IMPD (2011).
• Preparation of the IMPD for the Phase I/II Clinical Trial on using amniotic membrane for skin replacement in big wounds.