Certified state-of-the-art technology platform to support Wyss Zurich projects to meet regulatory standards
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 is a lean, academic facility for Good Manufacturing Practice (GMP), which comprises GMP specialists and GMP infrastructure.
The Platform provides the expertise, guidance and infrastructure required to respond to the unique and diverse challenges of Wyss Zurich projects in the field of Regenerative Medicine. It aims to support Wyss Zurich projects in the efficient translation of basic biomedical research to applied regenerative therapies, and to accelerate entry of their innovative treatments into clinical trials. In particular, the existing and increasing demand for the clinical application of newly developed drugs and Advanced Therapy Medicinal Products (ATMPs) is addressed.
In addition, Wyss Zurich has recently established product development processes in alignment with the international standard ISO 13485 to support and accelerate the growing number of medical device projects. Application of these quality procedures aims to ensure that Wyss Zurich projects developing medical devices meet the regulatory requirements.
Support is provided through the following departments, infrastructure and services:
ISO 13485 for Medical Devices
CTO 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 has studied Environmental Sciences at ETH Zurich and received his PhD 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.
Monika Bauer joined Wyss Zurich in 2016. As Scientific Associate in Quality Control her focus is on flow cytometry and bioassays. She received her diploma in chemistry from the University of Freiburg and did her doctorate in the field of viral immunology (Institute of Microbiology and Hygiene, Freiburg). After postdoctoral research at the Free University of Berlin investigating mechanisms of peripheral pain she joined Cytos Proteome Therapeutics as Senior Scientist working on drug discovery. In 2002 she moved to Cytos Biotechnology. There she led the Flow Cytometry Unit and co-invented the eMAB® platform used for the development of fully human therapeutic antibodies. In 2010 Monika was hired as Senior Scientist Specialist by Intercell to continue her work on human therapeutic antibodies resulting in numerous publications and patents.
Microbiology Technician QC
Michaela Binal joined Wyss Zurich in August 2016. She works in the Quality Control department as a microbiology technician. She is in charge of achieving diverse microbiological tasks such as the environmental monitoring of the Wyss Zurich GMP facility. Before joining Wyss Zurich, she acquired experience as a lab technician in a Swiss Food Company where she was involved in various activities such as the control of raw materials and In-process controls. Already there, she ran routinely the microbiological monitoring in a regulated environment. Michaela has achieved her education as a biotechnological assistant at the Justus-von-Liebig-Schule in Waldshut in 2013.
Assistant Quality Management
Em Dang joined Wyss Zurich as Assistant for the Quality Management group in March 2016. She is responsible for the administration of the document and training management system. In addition, she supports the warehousing team. Em was educated as a bookseller followed up by advanced training at commercial school. She has long-standing experience in administration and customer relationship management.
GMP Officer Production
Martina Dragic joined Wyss Zurich as GMP Officer Production in April 2017. In her position, she builds an important interface between the production and the quality management group. After her apprenticeship as a chemical lab technician, Martina obtained a Bachelor in Biotechnology, with major in Pharmaceutical Technologies, at the Zurich University of Applied Sciences (ZHAW) in 2008. As Head of Production and QP delegate, she was working for 6 years at the Center for Radiopharma-ceutical Sciences of ETH Zurich. Martina also managed projects from bench to bedside for First-in-Man clinical studies and gained wide experience in field of production, quality control, quality management and regulatory affairs. In 2014, she joined the Center for Radiopharmaceuticals of the University Hospital Zurich, which is the leading manufacturer of radioactive pharmaceuticals in Switzerland. With her extensive knowledge, she helped to build up a new production site and acted as head of production deputy.
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 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).
Quality Manager Projects
Lisa Grabner joined Wyss Zurich in September 2017. In her role as Quality Manager Projects she supports production and project teams to ensure GMP compliance and to guarantee quality, safety and efficiency of the manufactured products. Lisa studied Biology at the University of Vienna and did research for her diploma thesis at the Clinical Institute of Pathology of the Medical University of Vienna. After graduating in 2012 she started her career in the Pharmaceutical Industry as part of the quality assurance team. In her position she worked closely with the manufacturing department to ensure compliance of the production area, process and products and to further improve quality standards. Lisa was mainly responsible for CAPA management, change control and risk management.
In her role as Quality Manager Ursina Graf supports the core competences of quality management of the Wyss Zurich platform for Regenerative Medicine Technologies, such as internal auditing, document management, non-conformance handling, change control and risk management. She was educated as druggist and has more than 10 years of work experience in strictly regulated environment (GMP, GLP) in microbiological quality control. Ursina holds a TÜV Certification in Quality Management and did advanced trainings in various GMP topics with special focus in auditing, microbiology and hygiene in GMP environment. She joined the former Swiss Center for Regenerative Medicine in 2010 as manager of the microbiology lab and developed into the role as Quality Manager of Wyss Zurich in 2015.
GMP Officer Quality Control
Mirjam Hediger joined the Wyss Zurich team as a GMP Officer Quality Control in September 2017. In her function, she represents an important interface between projects teams, QC and QM. Mirjam obtained a Bachelor in Chemistry with specialization in Biochemistry at the Zurich University of Applied Sciences (ZHAW) in 2009. Afterwards Mirjam worked in the Quality Control Laboratory in a pharmaceutical company. The last five years she was deputy manager for raw materials and monitoring in the Chemical Quality Control Unit of CSL Behring in Bern. Mirjam has experiences working accordingly different pharmacopoeias in a GMP environment as well as in handling changes, deviations and writing SOPs.
Scientific Associate Quality Control
Simon Hostettler joined the Wyss Zurich Regenerative Medicine Platform in March 2018. As Scientific Associate in Quality Control, he is responsible for the implementation of new analytics, method and process validation as well as instrument qualification. Simon studied Molecular Biology at the University of Basel, which he concluded with a Master’s Degree in 2010. Before assuming his current role, Simon gained experience in a regulated environment within a leading diagnostic company in Assay Development in the role of a Scientist.
Stock Manager / Administration
Eldina Kovac is a Pharmaceutical Assistant with commercial education, responsible for the warehouse management and administrative duties. The proven experience in pharmaceutical warehousing combined with her administrative education, makes her a valuable member of the GMP team. Her long gained experience in different teams brings a value to the translation of academic projects.
Christoph Meienhofer joined Wyss Zurich in April 2015 as a member of the production translation team. Due to his technical flair, he is responsible for the maintenance, qualification and validation of equipment and production process of Wyss Zurich projects. Thanks to his long experience in the pharmaceutical regulatory environment, he brings the knowledge to the translational project. He gained his experience during his 8 years in the production department of a world leading vaccines company Crucell (Johnson&Johnson) as a shift leader in GMP cleanroom production. He was responsible for pharmaceutical production, monitoring and maintenance of Hepatitis A vaccines. He started his career with a degree in nutrition technology and did by work an education as a technical merchant. In this phase, he gained experience in analytical and R&D processes.
Janine Muller is the main responsible for the training system of the Wyss Zurich platform for Regenerative Medicine Technologies. In addition, she supports further core competences of quality management such as document management, internal auditing, non-conformance handling, change control and risk management. Janine has longstanding experience in administration and organization of large business units with specific focus in university and medical environment. She holds a CAS in Quality Management from the ZHAW School of Engineering and did advanced trainings in various GMP topics and project management. She joined the former Swiss Center for Regenerative Medicine in 2009 as lead of the administration office and project coordinator, and developed into the role as Quality Manager of Wyss Zurich in 2015.
Senior Quality Manager
Michael Nägeli joined the Wyss Zurich Regenerative Medicine Platform in July 2018 as Senior Quality Manager. He supports production and project teams to guarantee compliance with applicable Quality/GMP standards. Michael studied Food Science at ETH Zurich with specialization in Biotechnology and received his PhD in 1998. He has 20 years of experience as Quality Manager within large global pharmaceutical companies and authorities like Swissmedic or US FDA. His professional experience covers all Quality/GMP aspects starting from API manufacturing (Grünenthal) to aseptically filled final products (CSL Behring). Moreover, Michael was involved in the development of a disposable bioreactor system (zeta). In his last role, he was Qualified Person and involved in more than 100 international audits as co- or lead-auditor.
Senior Quality Manager
Pia Radmer joined the Wyss Zurich Regenerative Medicine Platform in May 2018. She is responsible for technical and regulatory GMP-compliance guidance of different project teams and support the product and process quality strategy. Pia received a scientific Dipl.-Ing. (BSc + MSc) in Biochemical Process Engineering from the University of Stuttgart (Germany) with the specialization in biotechnology and biomedical engineering for development of manufacturing processes. Her professional experience covers process knowledge in manufacturing biologics (monoclonal antibodies, viral/RNA vaccines) from mammalian cell cultures as well as cell based therapies and class III medical devices. She has about 16 years experiences in working with large global pharmaceutical and biotechnology companies including 6 years as independent consultant for global product launches, technology transfers and technical investigations. Pia is a certified GMP-Auditor for supplier/CMO qualification, commercial market quality issues/improvements as well as inspection readiness.
Head of Medical Device Quality Management
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 was trained as a Biochemist at the Private University of Witten-Herdecke in Germany and received a PhD 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 PhD, Karola 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 brings valuable practical experience to support medical device projects through their translational process. Karola 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 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 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 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.
QC, Head of Microbiology – Hygiene Officer
Since February 2016, Magali Schnell is a member of the Quality Control team and rolls up her sleeves to guarantee optimum working conditions in the GMP facility of Wyss Zurich. In the QC lab, she supervises the microbiology activities but also participate to method validation or instrument qualification. Before joining Wyss Zurich, Magali gained experience in GMP environment within Pharmaceutical Industry by working as a Bioanalyst QC. Previously, she worked as Scientific Assistant (University of Geneva) and as Post-Doc in Italy (Università degli Studi di Udine) and in France (Institut des Sciences du Végétal – CNRS). She achieved her PhD in Molecular Plant Physiology at the University of Zurich in 2008 and firstly obtained her Diploma in Biology at the University of Neuchatel.
Quality Manager Medical Devices
Miriam Skilandat joined the Medical Device Unit at Wyss Zurich in April 2018. Her responsibilities include the maintenance and development of the quality management system and support of Wyss Zurich projects in establishing ISO 13485-compliant processes for their product design and development. Miriam obtained a Master’s degree in Molecular Life Sciences at the University of Luebeck. After graduating with a PhD in bioinorganic chemistry from the University of Zurich in 2014, Miriam joined Roche Diagnostics as a Product Quality Engineer for in-vitro-diagnostic instruments. In this role she gained substantial experience in GMP, GDP, change and deviation management as well as trend and statistical process analysis.
QP GDP / 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 studied foreign languages and has a longstanding experience in administration and customer relationship management.
Scientific Associate Quality Control / Lab Technician Biobank
Dario Studer joined Wyss Zurich in May 2018, where he is currently working as a Scientific Associate in Quality Control and Lab Technician at the Cell- and Tissue Biobank (CTBB) of the Regenerative Medicine Technologies Platform. His main tasks are to perform routine analytical methods for QC including In-Process Control (IPC) and product release assays. Dario is also involved in implementation tasks in the QC Lab like method validation and instrument qualification, moreover he provides services for the Biobank. Previously, during his Bachelor studies at the Zurich University for Applied Sciences (ZHAW), he participated in the development of preclinical cell-based-assays. Dario gathered as well experience in Clinical Study execution at the Swiss TPH.
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 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 Supplier Quality Assurance (SQA) and Cell- & Tissue Biobank (CTBB)
Steffen joined Wyss Zurich in 2009. He is leading the Cell- and Tissue Biobank (CTBB) and is responsible for the Supplier Qualification Assurance (SQA). He earned a doctorate (Dr. rer. nat.) from the ETH Zurich, Switzerland. Steffen has built up the CTBB with validated workflows ensuring an uninterrupted cooling chain, which applies a qualified central IT-system. Steffen is representing CTBB in various national and international associations, such as SBP, GDK e.V. and ESBB. In order to assure supplier conformity Steffen is leading audits at external stakeholders, being accountable for quality assurance agreements.
Steffen is co-founder of the International Placenta Stem Cell Society (IPLASS), founder and leader of the NTN-biotechnet platform “Regenerative Medicine” and an active member of several additional associations and organizations.
Scientific Associate Quality Control
Andrea Zischka joined the Wyss Zurich team in November 2017. In her role as a Scientific Associate in Quality Control she is responsible for various tasks in microbiology and analytics. She is involved as well in hygiene supervision as Hygiene Officer deputy. In 2013 she obtained a master`s degree in Biology, specialized on Botany at the Karl-Franzens-University Graz (Austria). Before assuming her current role, Andrea gained experience in GMP environment within a leading diagnostic company, working as a Specialist in Sensor Operations and in the function as a Specialist in Quality Assurance.