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:

Production

  • 800 sqm total footprint; thereof a total area of about 200 sqm with grade A, B, C, D and E pharmaceutical clean room
  • Five separate grade B and C clean rooms for handling different kinds of manufacturing projects for drugs and ATMPs
  • Grade D clean room designed for preparation and packaging
  • Qualified autoclave for steam sterilization
  • Qualified equipment for the production of drugs and ATMPs (e.g. particle-monitored class II safety work benches, CO2-incubators, refrigerators, freezers, refrigerated centrifuges, inverse microscopes, CliniMACS Prodigy® for automated cell processing, NucleoCounter for automated cell counting, etc.)
  • Continuous monitoring of critical parameters (particle, differential pressure, temperature, CO2 concentration) from the safety work benches, incubators and storage locations
  • Swissmedic manufacturing license (GMP) and distribution license (Good Distribution Practice, GDP) for Investigational Medicinal Products (IMPs) (drugs and ATMPs)

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
  • Method validation and process Validation 
  • Supplier qualification (internal and external audits)
  • Initial and continuous training of personnel

Quality Control

  • QC lab with qualified equipment for the quality control of drugs and ATMPs (e.g. flow cytometer, UV-VIS spectrometer, infrared spectrometer, PCR, NucleoCounter for automated cell counting, hematology analyzer, etc.)
  • Qualified equipment for bacterial endotoxins testing (Endosafe®-PTS™)
  • Microbiological monitoring of surfaces, airborne particles and airborne microorganisms

Biobank

  • Qualified storage tanks for storing cells in the vapor phase of 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
  • Templates for Design History File documents and further required documentation for regulatory purposes
  • Training and support in Quality Management and regulatory issues


Download
Regenerative Medicine Technologies fact sheet



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