Regenerative Medicine Technologies

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

Wyss Zurch 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

Wyss MOU Regen 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)
Wyss MOU Regen 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
Wyss MOU Regen Quality Control

Quality Control

  • Analytical batch release and in-process control of drugs and ATMPs incl. method verification/validation and optimization in compliance with Good Manufacturing Practises
  • Release of raw material and consumables
  • Environmental monitoring (airborne particles, surfaces and airborne microorganisms) of the GMP facility incl. hygiene training and Microbiological assays (e.g. sterility and growth promotion assay)
  • QC laboratories with qualified equipment and personnel
Wyss MOU Regen Biobank

Biobank (GMP)

  • Cryogenic asservation (capacity: 150’000 2 ml tubes) down to -196 °C (gas phase N2) of biological material (incl. GMOs) up to max. BSL-2
  • Operating license from Swissmedic since 2012, according to EU-GMP standards for the cryogenic preservation of TpPs/ATMPs for future clinical intervention FIM studies
  • 24/7 temperature monitoring and redundant alarm and on-call system
  • Validated electronic sample management system
Wyss MOU Regen 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

Impressions

Mikroskop Bruederli, Regenerative Medicine Technologies

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

Swissmedic Innovation Office @ Wyss Zurich

Swissmedic Innovation Office offers individual on-site meetings to spin-offs and SMEs. This initiative is supported by Wyss Zurich and the Division for Business and Economic Development of the Canton of Zurich. The meetings will take place in the premises of Wyss Zurich. The Business and Economic Development supports communication and promotion of the service.

Platform Management Team

Portrait kayser 560

Martin Kayser

Head Regenerative Medicine Technologies CTO / QP GMP

Gabriela gaechter portrait

Gabriela Gächter

Head of Quality Management

Irene Jost 560

Irène Jost

Head Medical Devices (ad interim)

Michael Naegeli portrait

Michael Naegeli

Head Supply Chain Management

Ulrike Schmidt Portrait

Ulrike Schmidt

Head of Quality Control

Rene stenger portrait

René Stenger

QP GDP / Head of Production

Iris szankowski portrait

Iris Szankowski

RMTP & Finance Coordinator and HR Manager

More about our projects

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