Advanced Therapy Medicinal Products (ATMP) are medicinal products for human use classified as either somatic cell therapy, gene therapy, or tissue engineered product. These products can be both autologous and/or allogeneic by nature and therefore include a wide range of therapeutic products. Over the past decades ATMPs have shown promising potential in the treatment of a variety of diseases such as cancer and autoimmunity. Over the last decade an increasing number of ATMPs received Marketing Authorization Approval status from the EMA and have consequently been integrated in the basic healthcare system.
Core Facility ATMPs
The production of ATMPs is strictly regulated and performed under GMP compliant conditions. In 2022, a central Core Facility was established in the Erasmus MC to facilitate ATMP development and effectively translate these promising products to our clinics and patients. The facility holds a manufacturing authorization license (108517F) and the GMP certification is currently under review for the production of ATMPs.
The Core Facility consists of a complete operational cleanroom facility and Quality Control (QC) laboratory and includes a comprehensive quality management system with accompanying quality and production personnel to assist in set-up and roll-out of production processes and associated clinical trials. The cleanroom facility consists of four grade B cleanrooms adjacent to one central C area. The B cleanrooms are fit for ML-II graded work activities if required. Currently, Dendritic Cell and TCR engineered T-cell products are produced while CAR-T-cell, oncolytic virus, and neoantigen peptide vaccine products are in preparation for production.
Given the importance of ATMPs to flourish within the clinics of the Erasmus MC and further solidify their place as treatment options yielding patient benefit, it is the Core Facility’s mission to effectively translate ATMPs to the clinic and accelerate and promote this field of translational research within the Erasmus MC.
Therefore, our aim is to support research groups in the effective translation of pre-clinical development results towards performance of clinical trials. We offer support in process and QC development as well as validation and set-up of the accompanying Investigation medicinal product dossier (IMPD) and Investigation Brochure (IB) to gain trial approval by the local competent authorities. After trial approval, the team offers support in the production activities and accompanying GMP requirements. Training and educational programs are in place to ensure performing operators are properly trained to perform the production activities.
In addition to internal users, the facility is open to CMO related work activities for external parties. Please contact us for further queries regarding this subject.