Centre of Excellence CREATIC Masaryk University, Faculty of Medicine

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MUNI | CREATIC — From lab to patient access

Your partner for the entire ATMP journey.

CoE CREATIC — the Central European Advanced Therapy and Immunotherapy Centre — is a Centre of Excellence at the Faculty of Medicine, Masaryk University, in Brno, Czech Republic. We connect research, product and process development, GMP manufacturing, regulatory expertise, clinical trials, data and evidence generation, and patient-access strategies to support the development of advanced therapy medicinal products (ATMPs).

We work with biotechnology and pharmaceutical companies, start-ups, academic research teams, hospitals and clinical partners. Whether you need a single specialised service, support for a defined development stage or an integrated programme across the ATMP lifecycle, CREATIC offers multiple ways to collaborate.

How we can support your development

• ATMP strategy and translational development

Define the pathway from an initial concept towards clinical development. Our support includes concept assessment, development planning, translational research strategy, experimental models, biomarker strategy, and identification of development risks and gaps.

• Process development and technology transfer

Move from a laboratory protocol towards a controlled manufacturing process suitable for clinical development. We support process optimisation and standardisation, manufacturing feasibility assessment, technology transfer, analytical methods, and the development of GMP-compatible procedures.

• GMP manufacturing and quality control

CREProFa, the CREATIC Production Facility, provides more than 1,000 m² of advanced research and manufacturing space, including specialised units for cell immunotherapy, gene therapies and biotechnology. Services include GMP process implementation, production of investigational advanced therapies within the authorised scope, aseptic processing, cell manipulation and expansion, cryopreservation, and quality-control testing.

• Regulatory affairs and quality strategy

Integrate regulatory requirements into development from an early stage. We provide regulatory assessments, gap analyses, phase-specific roadmaps, documentation review, support for interactions with competent authorities, and expertise in ATMP-specific requirements, GMO considerations and the Hospital Exemption pathway.

• Clinical development and clinical trials

Through close integration with CZECRIN — the Czech Clinical Research Infrastructure Network — we provide access to clinical development strategy, study design, protocol development, regulatory and ethics submissions, site feasibility, trial management, monitoring and multicentre study coordination.

• Clinical network and access to patients

Through CZECRIN, CREATIC connects development with a national network of clinical trial units, university hospitals, specialist centres and experienced investigators. A coordinated network of Phase I units supports early clinical development, including first-in-human studies. European research connections also support cross-border collaboration and multinational clinical research.

• Data, biostatistics and pharmacovigilance

Build the evidence needed for development and decision-making. Our capabilities include clinical data management, database design, statistical planning and analysis, bioinformatics, patient registries, real-world evidence, safety monitoring and reporting.

• HTA, pharmacoeconomics and patient access

Plan beyond regulatory approval. We support health technology assessment, pharmacoeconomic evaluation, cost-effectiveness analysis, payer evidence planning, reimbursement strategy and sustainable financing concepts for advanced therapies.

• Valorisation, partnerships and open access

Translate research outputs into products, services and collaboration opportunities through support for technology transfer, intellectual property strategy, commercialisation pathways, business development and partner identification.

• Education and training

Build the skills needed to develop and deliver advanced therapies. Together with our European partners and CZECRIN Academy, we offer training for researchers, clinicians and developers, including eight micro-certified courses in advanced therapies.

Flexible ways to work with us

Our Open Access model enables collaboration through expert consultation, specialised services, defined development work packages, infrastructure access, joint research and development, clinical development partnerships or integrated ATMP development programmes.

Let’s move your ATMP forward.

Tell us where you are in your development journey and what expertise or infrastructure you need. Together, we can identify the next steps towards clinical development and sustainable patient access.

🌐 www.creatic.muni.cz