Regenerative Medicine Technologies

Certified state-of-the-art technology platform to support Wyss Zurich projects to meet regulatory standards.

Wysszurich keyvisual Reg Med platform

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

Services provided

Production

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

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

Quality Control

  • QC lab with qualified equipment
  • Microbiological monitoring of surfaces, airborne particles, and airborne microorganisms
Biobank

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

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

Entrepreneurship

  • Product and process development
  • Providing regulatory expertise to enable early clinical trials

Impressions

People walking into the clean room at the Regenerative Medicine Technologies Platform

Discover here the platform of Regenerative Medicine Technologies with clean rooms, machines, storerooms, and offices.

Platform Management Team

Portrait kayser 560

Martin Kayser

Head of Regenerative Medicine Technologies Platform

Portrait leuthard 560

Patrick Leuthard

Chief Operating Officer

Iris szankowski portrait

Iris Szankowski

HR Manager & Platform Coordinator

Gabriela gaechter portrait

Gabriela Gächter

Head of Quality Management

Ulrike schmidt portrait

Ulrike Schmidt

Head of Quality Control

Miriam skilandat portrait

Miriam Skilandat

Head Medical Devices

Rene stenger portrait

René Stenger

QP GDP / Head of Production

Steffen zeisberger portrait

Steffen Zeisberger

Head Cell- & Tissue Biobank (CTBB)

More about our projects

Discover the projects that have been supported by the Regenerative Medicine Technologies platform, among others.