ICAT
Innovation Center for Advanced Therapies
The Innovation Center for Advanced Therapies (ICAT), located at Utrecht Science Park, is a high-quality infrastructure that accelerates innovative cellular, gene and tissue engineering therapies. ICAT supports high standards of patient care in The Netherlands at reasonable costs. Many of these innovative medicinal products (ATMPs) are manufactured through cell and tissue engineering, raising a unique set of biological, technological, logistical and regulatory issues that make them significantly different from conventional medicines. Within ICAT, the open innovation, GMP Simulator and cleanroom facilities centralize key expertise from all domains and utilize state-of-the-art equipment to form the bridge between concept and clinical implementation.
Infrastructure and User Services
ICAT serves as a national center of excellence, uniting stakeholders and experts across all disease areas within the Advanced Therapy Medicinal Products (ATMP) field. By engaging at an early development phase, ICAT maximizes the potential for therapeutic success.
Researchers—both internal and external—with innovative advanced therapy concepts gain access to cutting-edge equipment, laboratories, and expert technical support. ICAT caters to a broad user base, including scientists, clinicians, start-ups, and spin-offs.
The facility includes a late-stage development laboratory spanning 252 m2 jointly used by the open innovation and GMP Simulation facilities. This space houses state-of-the-art bioreactors for cell therapy and viral vector production, alongside advanced 3D bioprinters for tissue engineering. ICAT is fully equipped for downstream processing of viral vectors, including purification, analytics, and quality control as well as quality control of cellular and tissue-engineered products.
At UMC Utrecht, the GMP facility has been significantly expanded, now including six additional class B cleanrooms and a dedicated analytical (QC) laboratory.
Within the GMP Simulation facility, a team of specialized experts supports researchers with analytical method development, process optimization, validation studies, and the transition to GMP-compliant manufacturing. Regulatory specialists ensure alignment with the latest standards and facilitate engagement with regulators and policymakers. The GMP facility is operated by a qualified team responsible for cleanroom management, equipment, and manufacturing processes, all maintained to full GMP standards. ICATs’ state-of-the-art facilities and experts also play a pivotal role in training and educating the next generation of ATMP professionals.
Examples/description of the type of research
ICAT will drive the advancement of gene, cell, and tissue therapies from proof-of-concept (equivalent to TRL3) through to clinical application. These advanced therapy medicinal products (ATMPs) often require optimized, or even fundamentally reimagined, production methods to move from initial concept to clinical practice. This is due to the challenges of scaling up or scaling out, as well as the rapid pace of technological development. Crucially, all production must align with Good Manufacturing Practice (GMP) standards, using a risk-based approach.
To bridge this gap, ICAT offers a state-of-the-art GMP Simulator facility, a dedicated environment that transitions research into GMP-compliant manufacturing. This simulation space acts as both a de-risking platform for manufacturing processes and a vital training ground for new personnel, all prior to entering full-scale production within ICAT’s GMP cleanrooms.
The ICAT GMP Simulator enables:
- Pre-clinical development in a setting that mirrors clinical conditions, allowing researchers to define the product’s critical attributes and optimize processes early on;
- Translational development, where laboratory-scale processes are adapted for GMP production—including tool development, scale-up, and the integration of regulatory-grade quality controls;
- Analytical method qualification and (pre-)validation, conducted in close collaboration with the GMP facility to ensure seamless transition into compliant production environments with results ready for regulatory approval.
Once a manufacturing process is validated, it is transferred to the GMP facility to support clinical testing in Phase I–III trials. If further optimization is required, the process can be cycled back into the GMP Simulator, ensuring continuous improvement and regulatory alignment.
How to access the infrastructure?
ICAT will provide access to a range of state-of-the-art facilities and services, combining access to ATMP expertise, specialised equipment, patient groups and clinicians. An Open Access program is established in which proposals for projects using the ICAT facilities can be submitted by potential users. A single point of access to all ICAT activities is available and by filling out a form to describe the project, indicate the type of support, phase of research project, technology or staff support needed. An evaluation board will assess the project based on scientific excellence, technical feasibility and expected scientific, societal and economic impact.