Services
Facility / Equipment
Clean Room Facility
Three fully equipped clean rooms for the in house production of ATMP.
The Clean Room Facility for cell and gene therapy is located at the 13th floor of the Ee-building. It consists of:
- One ladies- and a gents changing room (1354, 1356) at the entrance.
- One sterile disposables storage room (1358).
- Two clean rooms for hematopoietic stem cell processing (1351a and 1351 b) connected with the central hall through a single lock room (1351).
- Three clean rooms (1357a, 1359a, 1361a) for the production of ATMP, which are each connected with the central hall through a lock room (1357, 1359, 1361).
The three clean rooms for ATMP production are ± 16 m2 each fully equipped for aseptic processing and in vitro culture. All clean rooms and associated lock rooms are qualified as cleanroom class C. An environmental monitoring program is operational to document the quality of the aseptic processing environment and provide information on environmental trends of the clean areas.
The 3 clean rooms for ATMP production are qualified for genetic modifications at ML-I and ML-II level. The entrance to the cleanroom facility is restricted to qualified personnel and regulated through a personal badge. Next to the clean room facility is a quality control laboratory and a room for the storage of cryopreserved products.
Quality management system
A comprehensive Good Manufacturing Practice compliant quality management system for the in house production of ATMP.
ATMP are medicinal products. Thus the production of ATMP has to comply with Good Manufacturing Practice (GMP) standards. A GMP-compliant comprehensive quality management system is operational, ensuring that all applicable quality and safety rules for the in house production of ATMP are met.
The quality management system includes:
- Training and qualification of personnel.
- Selection and qualification of raw materials.
- Document control.
- Process validation.
- Validation, maintenance and calibration of equipment,
- Environmental monitoring of the clean rooms.
- Release of ATMP end products by a Qualified Person.
- Internal audits.
- Registration of errors, accidents and adverse events.
- Participation in external proficiency testing programs.
In addition, written policies regarding processing, quality controls, storage, release and transport of cell and gene therapy products are operational.
Support
Preparation of an ATMP-specific product dossier
The ATMP facility supports researchers in writing the IMPD for their ATMP.
The Investigational Medicinal Product Dossier (IMPD) is the basis for approval of clinical trials by the competent authorities. The IMPD includes summaries of information related to the quality, manufacture and control of the Investigational Medicinal Product. An overall risk-benefit assessment, critical analyses of the non-clinical and clinical data in relation to the potential risks and benefits of the proposed study have to be part of the IMPD.
Over the years, the ATMP facility has acquired knowledge and experience on writing an IMPD for ATMP which are intrinsically complex products derived from a variety of biological materials, such as cells, tissues or viral vectors.
The ATMP facility supports researchers in writing the IMPD for their ATMP.
A manual to develop and write an IMPD for an ATMP and an example of a CCMO-approved IMPD for an ATMP are available.
Center of expertise for ATMP
Through the Center of Expertise, developers of ATMP are supported to bring their advanced products to the clinic.
The translation from pre-clinical research with ATMP to clinical application in patients requires extensive knowledge regarding regulatory issues (types of permits required and procedures for obtaining them) and many aspects in relation to the preparation of these medicines (GMP-compliant quality system, clean room facilities, SOP's and product documentation (IMPD) etc.
Specific knowledge and experience regarding the production process of an ATMP or study with an ATMP is often absent with researchers. The constantly renewing regulation is difficult to understand. For most researchers the understanding of these regulations does not have priority.
Through the Center of Expertise, developers of ATMP are supported to bring their advanced products to the clinic. Researchers are supported during the preparatory phase preceding the clinical study. The Center of Expertise helps to navigate through the regulatory framework, to prepare the ATMP-specific dossier including the investigational medicinal product dossier and to obtain the required permits for the production and clinical application of the ATMP. In addition, researchers are assisted with the translation of the research production protocol into a GMP-compliant production protocol. This includes the upscaling of the procedure, the replacement of research grade ingredients with GMP compliant ingredients and the transition of an open production system into a closed production system, when possible. We also advise on the design of in process quality controls and the specification of the release criteria of the final ATMP product.