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Introduction

The ATMP facility supports bench-to bedside development of innovative ATMP based therapies.

ATMP comprise 3 types of products. These are:

  • Manipulated somatic cell therapy products.
  • Gene therapy products.
  • Tissue engineered products.

ATMP hold great promise for the development of new treatment approaches for a variety of serious diseases. As a result of the implementation of the European Directive 1394/2007 on advanced therapy medicinal products, ATMP are considered to be medicinal products. This implies that the preparation of ATMP for clinical application has to comply with all legal regulations for the production of medicines.

Over the past few years, significant progress has been made in the development of novel ATMP. However, the step from basic and translational research to clinical trials is challenging. This is mainly due to the complex nature of the ATMP production process and the regulatory framework governing ATMP production.

Mission statement
The mission of the ATMP facility is to support ATMP developers within Erasmus MC to bring promising innovative cellular therapies into clinical trials. In order to do this, a core of expertise on ATMP was established in the ATMP Center of Expertise.

The ATMP Center of Expertise supports researchers to navigate through the regulatory framework, to prepare the ATMP-specific product dossier and to obtain the required permits for the production and application of ATMP in clinical trials. In addition, the Center of Expertise  assists in the translation of the research production protocol into a GMP-compliant production protocol and provides clean rooms and a GMP-compliant quality management system for the in house production of ATMP for clinical studies.

The ATMP facility also provides a training program for researchers and technicians to qualify for the production of an ATMP in a clean room environment. Finally, the ATMP facility holds a Good Manufacturing Practice (GMP) license for the production of ATMP. This is a legal prerequisite for the in house production of ATMP for application in clinical trials.

Examples of ATMP:

  • Monocyte-derived dendritic cells loaded with tumor antigens (see figure). 
  • Genetically-modified T lymphocytes expressing a tumor-specific T cell receptor.
  • Ex vivo expanded umbilical cord blood-derived hematopoietic stem and progenitor cells.

Introduction