Hudson Cell Therapies

Facility

Hudson Cell Therapies (HCT) operate within a PC2 & ISO 8 certified clean room facility and house an adjacent vapour phase LN2 cryopreservation suite operated to ISO 15189 standards.

Hudson Cell Therapies is qualified to receive, store and distribute human cellular therapy product in support of multi-site clinical cell therapy trials. All equipment is qualified and maintained according to our Quality Management Plan and relevant Australian standards

Quality and production

Hudson Cell Therapies

Hudson Cell Therapies is capable of manufacturing minimally manipulated human blood and tissue products for early phase HREC approved investigator lead clinical trials with TGA CTN notifications. All projects are risk assessed by our Quality team ahead of development and implementation of processing protocols compliant with the Australian Regulatory Guidelines for Biologicals.

In addition, the Quality team is available on a consultancy basis to assist with a wide range of quality and regulatory concerns. Services can be modular and designed to integrate with existing practices where necessary.

The Quality team can give advice on adherence to and navigation of pertinent regulatory standards including but not limited to

Hudson Cell Therapies
  1. Therapeutic Goods Administration (TGA) guidelines on cGMP compliance
  2. ISO Standards such as 15189, 14644, 13485 and 9001
  3. Foundation for the Accreditation of Cellular Therapy (FACT) Standards.

The team can also assist with the development and creation of documentation, including

  • Validation protocol creation and execution
  • Critical sample/material control
  • Sample tracking, custody and handover
  • Processing and Cryopreservation
  • Audit (internal/supplier/collaborator)
  • Tech transfers
  • Quality Control advice and implementation

Contact us

General enquiries | hudson-ct@hudson.org.au

Dr Gordon McPhee | Facility Manager
Hudson Cell Therapies
Hudson Institute of Medical Research | Translational Research Facility
t: +61 3 8572 2802
e: gordon.mcphee@hudson.org.au

Dr Mirja Krause | Quality Manager
Hudson Cell Therapies
Hudson Institute of Medical Research | Translational Research Facility
e: mirja.krause@hudson.org.au