Ensuring consistent accountability and reproducibility while providing clients with high quality outcomes and confidence in our services.
Ensuring consistent accountability and reproducibility while providing clients with confidence in their results.
Hudson Institute Cell Therapies is the only facility of its kind outside the Melbourne CBD. Located within the Monash Medical Precinct, we have the advantage of being on the doorstep of clinicians at Monash Medical Centre and researchers at Hudson Institute and Monash University.
Current NATA ISO:15189 accreditation for cell processing services. No: 21322
Fully certified ISO8 clean room facilities.
Co-located ISO:15189 accredited cryopreservation capabilities.
Hudson Institute Cell Therapies is the only facility of its kind outside the Melbourne CBD. Located within the Monash Medical Precinct, we have the advantage of being on the doorstep of clinicians at Monash Medical Centre and researchers at Hudson Institute and Monash University.
Current NATA ISO:15189 accreditation for cell processing services. No: 21322
Fully certified ISO8 clean room facilities.
Co-located ISO:15189 accredited cryopreservation capabilities.
Hudson Institute Cell Therapies is the only facility of its kind outside the Melbourne CBD. Located within the Monash Medical Precinct, we have the advantage of being on the doorstep of clinicians at Monash Medical Centre and researchers at Hudson Institute and Monash University.
Current NATA ISO:15189 accreditation for cell processing services. No: 21322
Fully certified ISO8 clean room facilities.
Co-located ISO:15189 accredited cryopreservation capabilities.
About Hudson Institute Cell Therapies
Hudson Institute Cell Therapies is an expert in Bone Marrow and Cord Blood Transplant Processing. In addition, HICT is capable of manufacturing minimally manipulated cellular therapy products (blood or tissue derived) for early phase HREC approved investigator lead clinical trials under the TGA CTN scheme.
Our Commitment to Quality
We prioritise safety and compliance in everything we do. Each project undergoes a comprehensive risk assessment by our dedicated Quality team, ensuring that all processing protocols adhere to the NATA ISO15189, NPAAC and the Australian Regulatory Guidelines for Biologicals. This meticulous approach guarantees that your cellular therapy projects are supported by the highest standards of quality and reliability.
For the first time on the Monash Medical Centre precinct, clinicians can access fast-tracked, accredited services and facilities; removing previous logistical challenges and improving patient experience.
HICT is qualified and accredited to receive, store and distribute human cellular therapy product in support of multi-stage clinical trials and standard of care procedures.
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 and ISO:15189 standards.
The Quality team is also available on a consultancy basis – services can be modular and designed to integrate with existing practices where necessary.
Meet the team
Dr Mirja Krause-Onwukwe
Service Operations and Quality Manager
Nancy Messino
Production Manager
Samuel Mwaniki
Production and Operations Technician
Siow Teng Chan
Production Supervisor
Meet the team
Dr Mirja Krause-Onwukwe
Service Operations and Quality Manager
Nancy Messino
Production Manager
Samuel Mwaniki
Production and Operations Technician
Siow Teng Chan
Production Supervisor
Our partners and collaborators
- Monash Health
- NATA
- RCPA
- ICCBBA
- Johnson & Johnson
- Novartis
- Bristol Meyers Squibb
- Gilead
- Cell Care
- BMDI
- Monash Children’s Hospital
- RNAte
- Cartherics
- FACT
- The Ritchie Center
- Cerebral Palsy Alliance
- Cell Therapies
Our partners and collaborators
- Monash Health
- NATA
- RCPA
- ICCBBA
- Johnson & Johnson
- Novartis
- Bristol Meyers Squibb
- Gilead
- Cell Care
- BMDI
- Monash Children’s Hospital
- RNAte
- Cartherics
- FACT
- The Ritchie Center
- Cerebral Palsy Alliance
- Cell Therapies
Quality and production
Hudson Institute 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
ISO Standards such as 15189, 14644, 13485, 9001 and 17025
Therapeutic Goods Administration (TGA) guidelines on cGMP compliance
Foundation for the Accreditation of Cellular Therapy (FACT) Standards
We 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)
Hudson Institute Cell Therapies (HICT) an expert in Bone Marrow and Cord Blood Transplant Processing. In addition, HICT is capable of manufacturing minimally manipulated cellular therapy products (blood or tissue derived) for early phase HREC approved investigator lead clinical trials under the TGA CTN scheme.
We 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)
Hudson Institute Cell Therapies (HICT) an expert in Bone Marrow and Cord Blood Transplant Processing. In addition, HICT is capable of manufacturing minimally manipulated cellular therapy products (blood or tissue derived) for early phase HREC approved investigator lead clinical trials under the TGA CTN scheme.
Validation protocol creation and execution
Critical sample/material control
Sample tracking, custody and handover
Processing and Cryopreservation
Audit (internal/supplier/ collaborator)
Hudson Institute Cell Therapies (HICT) an expert in Bone Marrow and Cord Blood Transplant Processing. In addition, HICT is capable of manufacturing minimally manipulated cellular therapy products (blood or tissue derived) for early phase HREC approved investigator lead clinical trials under the TGA CTN scheme.