The platform provides the expertise, guidance and infrastructure required to respond to the diverse regulatory and technical challenges of Wyss Zurich projects in the field of Regenerative Medicine. It aims to support Wyss Zurich projects in the efficient translation of biomedical preclinical research into applied regenerative therapies, and to accelerate entry of innovative treatments into clinical trials. In particular, it addresses the existing and increasing demand for the clinical application of newly developed drugs and transplant products (TpPs, also called Advanced Therapy Medicinal Products, ATMPs).

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. Application of these quality procedures aims to ensure that Wyss Zurich projects, which develop medical devices, also meet the regulatory requirements.

Support is provided through the following departments, infrastructure and services:

Manufacturing (GMP)

  • 800 sqm facility; including clean rooms of 200 sqm (GMP grade A, B, C, D)
  • Five separate GMP grade B and C clean rooms for handling different kinds of cell culture manufacturing processes for drugs and TpPs/ATMPs
  • Grade D clean room designed for preparation and packaging
  • Qualified autoclave for steam sterilization of equipment and material
  • Qualified equipment for the production of drugs and TpPs/ATMPs (e.g. particle-monitored class II safety cabinets, CO2 incubators, refrigerators, freezers, refrigerated centrifuges, inverse microscopes, CliniMACS Prodigy® for automated cell processing, NucleoCounter for automated cell counting, etc.)
  • Continuous monitoring of clean room parameters (airborne particles, differential pressure, temperature, humidity) of the safety cabinets, incubators and storage locations
  • Equipment qualification and technical process verification
  • Manufacturing of products under GMP conditions for clinical supply

Quality Management (GMP)

  • Swissmedic manufacturing license and Certificate of GMP Compliance for drugs and investigational drugs (including aseptically manufactured products)
  • Swissmedic manufacturing license and Certificate of GMP Compliance for investigational cell therapy products, investigational tissue products and investigational ex vivo gene therapy products
  • Certified Quality Management System (e.g. Master Standard Operating Procedures, Deviation Management, Change Control Management, Risk Management, etc.)
  • Review and approval of all GMP/GDP-relevant documents in order to guarantee compliance with GMP/GDP regulations
  • Assurance of the quality system and inspection readiness
  • Quality assurance of the GMP standards of the Wyss facility including all departments and project teams (e.g. training status etc.)
  • Advice for project teams on scientific compliance from senior GMP experts (project-specific strategies)
  • Supplier selection and qualification (external audits)
  • Compliance direction for all GMP/GDP-relevant issues
  • Assurance of batch release process for clinical trials

Quality Control (GMP)

  • Analytical batch release and in-process control for clinical supply, stability studies, transport studies, process verification runs, etc.
  • Release of raw material and consumables
  • Review and approval of GMP documentation
  • QC laboratories with qualified equipment for the analytical testing of drugs and TpPs/ATMPs (flow cytometer, hematology analyzer, microscopes, endotoxin measuring device, thickness measuring system, etc.)
  • Environmental monitoring of the GMP facility (airborne particles, airborne microorganisms, surface microorganisms, including identification of germs)
  • Microbiological assays (e.g. sterility and growth promotion assay)
  • Optimization of analytical methods including method verification and validation
  • Equipment qualification
  • Initial qualification and continuous training of personnel

Hygiene (GMP)

  • Hygiene assurance of the clean room at the Wyss Zurich facility
  • Responsible for the cleaning standard of the clean rooms and laboratories
  • Initial qualification and continuous training of personnel

Biobank (GMP)

  • Qualified cryo infrastructure for controlled freezing and storage of e.g. therapeutic relevant cell and tissue samples (e.g. master and working cell bank) in the vapor phase of liquid nitrogen
  • -80°C freezers for sample storage
  • Cryogenic workbench
  • Qualified sample management

Good Distribution Practice, GDP

  • Review and approval of GDP documentation
  • Established collaboration with GDP-compliant couriers
  • Swissmedic distribution license (Certificate of GDP Compliance) for drugs and TpPs/ATMPs

ISO 13485 for Medical Devices

  • Quality Management processes according to ISO 13485 for development of medical devices
  • Templates for technical documentation required for regulatory purposes
  • Training and support of medical device projects in Quality Management and regulatory aspects


Download
Regenerative Medicine Technologies fact sheet



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