Advanced Therapy Medicinal Products Production Unit (ATMP-PU)
Mission
The Advanced Therapies Medicinal Products Production Unit is a Research Support Service that supports research in the field of Advanced Therapies and Regenerative Medicine. The SAI is part of the IISGM Cell Platform.
Description
The Advanced Therapy Medicinal Products Production Unit (UP-MTAs) is a Research Support Service that provides comprehensive support for preclinical and clinical research in the field of Regenerative Medicine and Advanced Therapies. In addition to producing Advanced Therapy Medicinal Products for use in clinical trials, the Unit supports projects in the early stages of development, including the production of batches for preclinical studies, as well as scientific, technical and regulatory advice for the translation of products from the preclinical phase to clinical research, in compliance with GMP requirements and current regulations.
The Unit comprises:
Cell Therapy Laboratory: a laboratory with a controlled environment (Classification D) for the clinical production of advanced therapy medicinal products (ATMPs) in closed systems. It also produces cells for in vitro preclinical trials in humans. For example, trials have been developed in areas such as Cardiology, Gynaecology, Maxillofacial Surgery, Traumatology, Dermatology, Oncology and General Surgery.
ATMP Production Unit: infrastructure that provides support for clinical research in Regenerative Medicine and Advanced Therapies. The Unit has been certified by the Spanish Agency for Medicines and Medical Devices (AEMPS) since February 2009, and was reaccredited for the fifth time in November 2022 (ES/099I/24) for the production of 15 Clinical Research Products (PEIs), 1 medicinal product and one medical device.
These products have been used in 30 clinical trials, conducted at our hospital and at other centres, both nationally and internationally, including participation in multicentre clinical trials.
Services offered
Preclinical studies in Advanced Therapies and Regenerative Medicine.
Production of various types of Advanced Therapy products for use in clinical trials, under infrastructure certified in accordance with Good Manufacturing Practice (GMP). Holding the following authorisations for investigational medicinal products granted by the AEMPS:
- Bone marrow mononuclear cells (PEI 05-042 and 13-037).
- Stromal vascular fraction of adipose tissue (PEI 11-027).
- Autologous mesenchymal cells from bone marrow (PEI 09-065 and 10-148).
- Allogeneic mesenchymal cells from bone marrow (PEI 12-088 and 14/094).
- Autologous mesenchymal cells from adipose tissue (PEI 09-019 and 11-164).
- Allogeneic mesenchymal cells from adipose tissue (PEI 15-103 and 22-031).
- Autologous quiescent mesenchymal cells from adipose tissue (PEI 21/113).
- Autologous mesenchymal cells from the periodontal ligament (PEI 13-143).
- Allogeneic NK cells stimulated with IL-15 (PEI 17-025).
- Autologous Treg cells from thymic tissue, stimulated with IL-2 (PEI 19-083).
- Allogeneic decellularised corneal sheet (PEI 21/114).
- Allogeneic Treg cells from thymic tissue, stimulated with IL-2 (PEI 22-185).
- Human type I collagen sheet produced by 3D printing.
Preparation of IMPDs (Investigational Medicinal Product Dossiers) and PNTs (Standard Operating Procedures). Validation and preparation of reports on new Advanced Therapy products to request their approval from the AEMPS.
Histology, immunohistochemistry and immunofluorescence of organs and tissues.
NOTE: All work is carried out within the framework of Good Laboratory Practice, Good Clinical Practice (GLP and GCP) and Good Manufacturing Practice (GMP); that is, a rigorous quality assurance system ensures robust results that can be easily transferred to clinical practice.
Technology
Therapy Laboratory (Grade D):
- BIO II-A TELSTAR Laminar Flow Hood
- CO2 Incubator
- AXIOVER40 Microscope with fluorescence
- Refrigerated centrifuge
- Barnstead MAXQ Mini 4450 shaker
- CliniMACS Plus cell separator
Quality Control:
- MacsQuant Analyzer 10 Flow Cytometer
- BioRad Thermocycler
- Gel Logic PCR Gel Analyzer
- Molecular Devices Luminometer
- Safefast ELITE Isolator
- HandiLaz Mini II Portable Particle Counters
- Microbiological culture ovens (37ºC and 22ºC)
- Endosafe® nexgen-PTS™
- AIR IDEAL 3P Air Sampler
- Data Loggers
- pocH-100i Haematology Analyzer
- LUNA-FX7 Automated Cell Counter
Production Unit (Grade A, B, C and D):
- TELSTAR BIO II-A Laminar Flow Hoods
- CO2 Incubators, with sterilisation cycle, Thermo 371 and STERI-CULT
- AXIOVER40 CFL Microscope
- EPPENDORF 5810R Refrigerated Centrifuge
- Portable particle counters
- Tissue disaggregator
- Automatic vial encapsulator
- Bag sealer
- Barnstead MAXQ Mini 4450 Shaker
- Bag thawer
- Freezers with controlled temperature ramp
- ThawSTAR CFT2 Automated Vial Thawer
- CryoPlus 340L N2 Tank
- Voyageur+ Cryogenic Transport System
- CliniMACS Prodigy Cell Processor
Installation
The Advanced Therapies Medicinal Products Production Unit has a facility that complies with the guidelines on Good Manufacturing Practices (GMP). It is located on floor -1 of the Clínica Building.
Documentation
Documented GMP Quality Assurance System with AEMPS accreditation. Latest valid certificate no. ES/099I/24, latest audit held from 23 to 25 November 2023.
Contact
Dr Mª Eugenia Fernández Santos
Technical Director
Advanced Therapy Medicinal Products Production Unit (ATM-Production Unit)
Email: mariuge(ELIMINAR)@fibhgm.org
Tel.: 91 529 05 20 / 21
Translational Research Laboratory in Cardiology
Gregorio Marañón Health Research Institute
Gregorio Marañón Maternal and Child Hospital
C/ O 'Donnell, 48, floor -1 (semi-basement, next to the Biobank).
28009 Madrid