Core Facilities
GMP laboratory

Head: Primaria Univ.-Prof. Dr. Eva Rohde, MD

At the GMP (Good Manufacturing Practice) laboratory of Paracelsus Medical University (PMU), the development and manufacturing of novel cell-based therapeutic products such as mesenchymal stem/stromal cells (Advanced Therapy Medicinal Products, ATMPs) and extracellular vesicles (biologics) take place. The clinical applications of these innovative therapeutics include implantation-induced and traumatic injuries, degenerative diseases of the musculoskeletal system, various immunological and neurological indications, as well as lesions resulting from acute traumatic spinal cord injuries. These cell therapies are tested in clinical trials conducted in collaboration with the University Hospital Salzburg and other partnering institutions.

Ensuring safety, efficacy, and effectiveness in the harvesting, manufacturing, and application of novel cell therapies is the core guiding principle of the GMP laboratory staff. Together with the GMP infrastructure, this provides a solid foundation for the clinical evaluation of innovative therapeutic concepts in the fields of vesicle-based therapy and regenerative medicine.

General Information

The laboratory holds a GMP certificate in accordance with § 63 AMG and is accredited for the manufacturing of MSC therapeutics for clinical trials. It ensures the maintenance of certified GMP-compliant production facilities at the Salzburg site, including integrated quality control and infrastructure for the storage of human stem cells and stem cell products under GMP-compliant conditions for clinical testing, as well as for research and development.

The market for CDMO activities supporting transformative regenerative approaches—with the goal of accelerating the complex establishment of pharmaceutical manufacturing for novel therapeutics—is growing exponentially. The advantages of partnering with a CDMO for cell or gene therapy include faster access to clinical trials, accelerated market entry, and access to technical expertise with high cost efficiency and without overhead costs.

Contract Development

The PMU’s GMP laboratory supports clients in developing GMP-compliant manufacturing processes in the field of cell- and vesicle-based therapies. The modular design of PMU’s GMP cleanroom environment enables the parallel execution of up to four manufacturing processes.

Contract Manufacturing

For clinical studies up to Phase II, contract manufacturing is possible at PMU’s GMP laboratory (depending on the process and product dosage). The GMP team has a proven track record of successfully meeting complex client requirements for process development and prototype production. The unique combination of state-of-the-art GMP infrastructure and the team’s expertise in cell, EV, and CDV manufacturing is widely recognized in the industry.

The Research and Development activities of PMU’s GMP laboratory focus on application-oriented, transdisciplinary research and on the transfer of research findings into education and industry, as well as the initiation of new research projects. Particular emphasis is placed on the parallel advancement of manufacturing and analytical methods to establish EV-based therapeutics for use in the field of regenerative medicine.