Hudson Cell Therapies
Hudson Cell Therapies Platform
Hudson Cell Therapies provides a facility for the safe, efficient and rapid manufacturing of human blood and tissue products.
Hudson Cell Therapies allows clinicians based in the Monash Medical Precinct and elsewhere to have blood products processed outside the Melbourne CBD for the first time, improving accessibility for clinical trials.
Operating within a PC2 & ISO 8 certified clean room facility and housing a cryopreservation suite operated to ISO 15189 standards, Hudson Cell Therapies is qualified to receive, store and distribute human cellular therapy products in support of multi-site clinical cell therapy trials.
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.
The Quality team is also available on a consultancy basis – services can be modular and designed to integrate with existing practices where necessary.
For further information contact our team below.
Quality and production
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
- Therapeutic Goods Administration (TGA) guidelines on cGMP compliance
- ISO Standards such as 15189, 14644, 13485 and 9001
- 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
Dr Mirja Krause | Quality Manager
Hudson Cell Therapies
