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Research Facility

ATMP

Expert center for the production of Advanced Therapy Medicinal Products.

Services

ATMPs

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.

ATMP Facility

The production of ATMPs is strictly regulated and performed under GMP compliant conditions. In 2022, a central 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 for production of ATMPs.

The ATMP 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, and oncolytic virus products are in preparation for production.



Support

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 ATMP 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.


Training & education

News, events & publications

About us

Our team

ATMP Facility Management

Sofieke de Wilde
Head ATMP Facility
Ruud Huisman Manager Team   

Carel Nicolai 

Head of Production

 

Quality team 

Figen Kahyargil-Agdere
QA and qualified person

 

Paula Leeflang QA officer
Liesbeth Ruijgrok Qualified person

 

Angela van Dorp

 

QA officer
  

Operator team

Ilknur Ozdemir-Goktas (Senior)
Myrthe Poncin (Senior)

DA Myrthe Poncin

Denise van den Beemt

 

Michael van der Reijden

 

Manon de Rijk

Kenny Mudde

DA Kenny Mudde

 

Zina Dammou

 

 

 

 

 

Funding

The build of the cleanroom facility was financially supported by the Support Casper Foundation.

Any questions?

Please contact our facility

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