The Regenerative Medicine Technologies Platform of Wyss Zurich is a fully certified state-of-the-art technical and scientific platform dedicated to manufacturing clinical grade products that meet the required stringent regulatory standards. The Platform provides the expertise and guidance required to respond to the unique and diverse challenges presented by the clinical translation of projects in the field of regenerative medicine.
As a lean, academic translational research facility for Good Manufacturing Practice (GMP), the Regenerative Medicine Technologies Platform aims at the efficient translation of basic biomedical research to applied regenerative therapies. The enrolment of clinical studies in the field of regenerative medicine and technologies according to Good Clinical Practice (GCP) is undertaken in collaboration with Swissmedic and the related international authorities (e.g. EMA, FDA).
The objective is to increase and optimize synergies of the various research and development activities at the University of Zurich and ETH Zurich, as a translational center (final common pathway towards clinical application). In particular, the existing and increasing demand for the clinical application of newly developed cell-based therapies is addressed. A state-of-the-art technology platform is created comprising a team of GMP specialists and professionally guided core facilities (clean-room technology, quality management, etc.). The aim is to routinely process patient cells for tissue engineering and cell-based therapies that can be used for clinical trials. A regional and national expertise and excellence in clinical applications (pilot studies, etc.) in the field of tissue engineering, organoid technologies and regenerative medicine will be established at the Regenerative Medicine Technologies Platform.
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Chief Technology Officer and Qualified Person
Having more than 15 years of experience in the field of pharmaceutical industry, Martin Kayser, leads the Regenerative Technology Platform of Wyss Zurich. As the CTO and Qualified Person he is responsible for the quality, safety and efficacy of the products produced in the GMP Facility. In addition, his focus lies on scientific and technological issues within the Wyss Zurich platform and is primarily concerned with long-term and "big picture" issues while still having deep technical and regulatory knowledge.
Martin Kayser has studied Environmental Sciences at ETH Zurich and received his Ph.D. in molecular science at the Institute of Microbiology (ETH Zurich) where he worked on the biodegradation pathways of halogenated hydrocarbons in different bacteria. He has a strong background in working in strictly regulated (GMP, GDP, GLP) environments as he worked in different positions in the pharmaceutical industry. He started as the head of a microbiological quality control lab and worked as the head of quality control for several years. In the function of the Qualified Person he worked in spin-off companies and finally as the head of GMP at the Swiss Center for Regenerative Medicine at the University Hospital Zurich.
Head of Quality Management
Gabriela Gächter joined Wyss Zurich in 2015 as Head of Quality Management. In this role she is responsible to maintain and further develop the quality management system of the GMP facility in order to guarantee the quality, safety and efficacy of the products manufactured, and to ensure compliance with regulations. Gabriela Gächter studied Pharmaceutical Sciences at the ETH Zurich and obtained her Swiss Federal Diploma for Pharmacists in 1994. She has more than 15 years of experience in GMP environment within the Pharmaceutical Industry. During her industrial career she gained expertise in all aspects of quality management with a special focus in non-compliance investigation, change control, and qualification and validation. She has actively participated in various health authority inspections (e.g. Swissmedic, EMEA, FDA, ANVISA).
Head of Medical Device Unit
Since May 2016, Karola Schlinkmann leads the new Medical Device Unit at Wyss Zurich, where she is responsible to establish, maintain and improve an ISO 13485-compliant quality management system to meet the regulatory requirements for the design and development of medical devices. Karola Schlinkmann was trained as a Biochemist at the Private University of Witten-Herdecke in Germany and received a Ph.D. in Biochemistry from the University of Zurich in 2012. During her doctoral studies, she was responsible for the coordination and execution of an international protein engineering project. After her Ph.D., Karola Schlinkmann worked as a Regulatory Affairs Specialist at a Swiss API contract manufacturer and joined the LifeMatrix project – one of the Wyss Zurich founding projects – as a project leader in May 2014. In this position, she was responsible for the project management, preclinical development and regulatory affairs of the tissue-engineered grafts regulated as class III medical device. From this role, Karola Schlinkmann brings valuable practical experience to support medical device projects through their translational process. Karola Schlinkmann has completed GMP- and GCP-trainings as well as several training courses for quality management systems and medical device development according to ISO 13485.
Head of Quality Control
Ulrike Schmidt is Head of Quality Control at the Wyss Translational Center Zurich since 2016. Her focus is set on elevating the microbial quality in the cleanrooms, and building solid analytical technologies to implement new modalities. She is managing diverse project teams and contract laboratories and is also responsible for the In Process Control. Ulrike Schmidt has gathered an extensive bio‑analytical development experience. The last ten years, she worked as Associated Director in the Quality Control in the Pharmaceutical Industry to validate and transfer new analytical methods of biologics for release tests and stability studies according to cGMP. At the same time she was responsible for managing projects of the clinical phase I and II, and technical transfers to commercial sites. Previously, Ulrike Schmidt worked for 4 years as a Post-Doc at the University of Zurich in the Department of Plant and Microbial Biology after achieving her PhD in Molecular Biology at the Max-Planck-Institute of molecular Plant Physiology in Potsdam, Germany. Originally she started her career at the Technical University of Berlin, Germany, by achieving her diploma and governmental certificate in Food Chemistry.
Head of Production
René Stenger is the Head of Production and Qualified Person for Good Distribution Practices (GDP) at Wyss Zurich. As a chemist with a postgraduate “Diplom” in Medicine-Technology-Management (Bern University of Applied Sciences), he has long lasting experience in the highly regulated industrial environment of medical devices and pharmaceuticals. In his former positions in several spin-off companies, as well as the Swiss Center for Regenerative Medicine of the University Hospital Zurich, he accompanied various translational projects in the field of regenerative medicine, e.g. a First-In-Man clinical study to evaluate the safety of autologous tissue-engineered dermal and dermal-epidermal skin substitutes for the treatment of large deep partial- and full-thickness skin defects in Children and Adolescent (University Children’s Hospital Zurich) and an open, monocentric phase I/II trial to assess the safety and feasibility of the autologous SCRM001_TEVG in pediatric patients with a congenital single ventricle heart defect.
Daniela Stoisor joined the Regenerative Medicine Technologies Platform of Wyss Zurich as Administrative Assistant in July 2015. She is responsible for office management and administrative coordination. Daniela Stoisor studied foreign languages and has a longstanding experience in administration and customer relationship management.
With her scientific background and long lasting experience in project management, Iris Szankowski is the Coordinator of the Regenerative Medicine Platform of Wyss Zurich.
Iris studied Biology at the Leibniz University Hannover, Germany, received her “Diplom” degree in 1998 and her Ph.D. (Dr. rer. nat.) in 2002. In the same year she was appointed as a Junior Professor at the Leibniz University and led a research group in the field of plant biotechnology and genetic engineering. From 2008 to 2010 she continued her research in plant genetic engineering at the Phytopathology group of the ETH Zurich and started with project management. In 2011 she joined the Hoerstrup research team at the University of Zurich. As a project manager, she coordinated large consortia, including three EU FP7 projects and managed several projects funded by the SNF, KTI and foundations. At Wyss Zurich she is the interface between the University of Zurich and ETH Zurich and leads the financial, administrative and human resources related operations.
Project Manager Process Development
Ellen Vogt joined Wyss Zurich as Project Manager Process Development in May 2015. Her pharmaceutical background combined with experience in project management will be very valuable to support and advance the translation of Wyss Zurich projects from research to first-in-man applications.
Ellen Vogt was educated as druggist and also obtained a Bachelor’s degree in Life Science Technologies from the University of Applied Sciences and Arts Northwestern Switzerland (FHNW). She worked for several years in the small-scale aseptic pharmaceutical production prior to joining the Tissue Biology Research Unit (University Children's Hospital Zurich) as Project Manager Regulatory Affairs. In this role, she was responsible for the Swiss Medic submission of a First-In-Man clinical study (EU FP7 EuroSkinGraft project) to evaluate the safety of autologous tissue-engineered skin substitutes for the treatment of severe skin defects. After receiving approval of this study by Swiss Medic early 2014, she went into the pharmaceutical industry and gained experience as a Project Manager Product Transfer at Akorn Pharmaceuticals Inc, prior joining Wyss Zurich.
Head of Biobank
Steffen Zeisberger is the Head of the Biobank of Wyss Zurich. He studied Biology in Mainz, Germany and received his “Diplom” degree in 2000. During that time and was involved in research activities in Germany, Switzerland and South Africa. In 2005 he received his Ph.D. (Dr. sc. nat.) from ETH Zurich and continued his research career as a Postdoctoral Fellow at, Institute of Obstetrics in the University Hospital Zurich where he was the head of laboratory. He guided several projects in the field of regenerative medicine towards the development of clinically relevant biomaterials and cell sources for prospective medical interventions at ETH Zurich, the University Hospital Zurich and the University of Zurich. Steffen joined the Swiss Center for Regenerative Medicine in 2009 and built up the biobank that is now integrated into Wyss Zurich.