Regenerative Medicine Technologies
Certified state-of-the-art technology platform to support Wyss Zurich projects to meet regulatory standards.
Abstract
The Regenerative Medicine Technologies Platform is a fully certified state-of-the-art technical and scientific platform dedicated to manufacturing clinical grade products.
The platform provides the expertise 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 innovative treatments into clinical trials.
In addition, Wyss Zurich has established product development processes in alignment with the international standard ISO 13485 to support and accelerate the growing number of medical device projects.
Support is provided through the following departments, infrastructure, and services:
Contact
Regenerative Medicine Technologies Platform
+41 44 634 56 74
regenerativemedicine@wysszurich.ch
Address
Regenerative Medicine Technologies Platform
Wyss Zurich Translational Center
Moussonstrasse 13
8044 Zurich
Regenerative Medicine Technologies Platform
Wyss Zurich Translational Center
Moussonstrasse 13
8044 Zurich
Services provided
Production
- 800 sqm total footprint; thereof a total area of about 200 sqm with grade A, B, C, D and E pharmaceutical clean room
- Qualified equipment for the production of drugs and TpPs/ATMPs
- Continuous monitoring of critical parameters (particle, differential pressure, temperature, CO2 concentration)
- Swissmedic manufacturing license (GMP) and distribution license (GDP)
Quality Management
- Certified Quality Management System (e.g., Master Standard Operating Procedures, Deviation Management, Change Control Management, Risk Management, etc.)
- Review and approval of documents for development, production, quality control and shipment
- Initial and continuous training of personnel
Quality Control
- QC lab with qualified equipment
- Microbiological monitoring of surfaces, airborne particles, and airborne microorganisms
Biobank (GMP)
- Qualified storage tanks for storing cells in liquid nitrogen
- -80°C freezers for sample storage
- Cryogenic workbench
- Validated database for sample management
ISO 13485 for Medical Devices
- Quality Management processes according to ISO 13485 for development of medical devices
- Training and support in Quality Management and regulatory issues
Entrepreneurship
- Product and process development
- Providing regulatory expertise to enable early clinical trials
Impressions
Discover here the platform of Regenerative Medicine Technologies with clean rooms, machines, storerooms, and offices.
Platform Management Team
More about our projects
Discover the projects that have been supported by the Regenerative Medicine Technologies platform, among others.