Servicing the south east corridor with the highest standard of care.
For close to a decade we have gathered experience. We are in close proximity to large hospitals and have strong clinical networks.
- Facilitation of global clinical trials
- Trial design
- Early phase trial support
- Support with expedited regulatory approvals (TGA CTN Scheme)
- Navigation of regulatory environment
- Manage product storage
- Translation from the lab bench towards a product
We have the capacity to store hundreds of cell therapy products, patient collections and retention samples.
- Validated vapor phase nitrogen storage
- Meets regulatory requirements
- Secure, monitored and controlled cryostorage optimised for cell therapy product storage
- Logistics related to clinical trials (product receipt, shipment and delivery), rapid, monitored and controlled.
- Controlled and monitored cold-storage at temperatures such as -20°C and -80°C.
We consult clients from research and industries alike. Our solutions are tailored to your product, trial and target market.
- Navigation of the regulatory landscape
- QMS set up and implementation
- QC advice and implementation
- Critical sample/material control,
- Validation protocol creation and execution,
- Audits
- Gap assessments and recommendations to meet regulatory requirements
Servicing the south east corridor with the highest standard of care.
For close to a decade we have gathered experience. We are in close proximity to large hospitals and have strong clinical networks.
- Facilitation of global clinical trials
- Trial design
- Early phase trial support
- Support with expedited regulatory approvals (TGA CTN Scheme)
- Navigation of regulatory environment
- Manage product storage
- Translation from the lab bench towards a product
We have the capacity to store hundreds of cell therapy products, patient collections and retention samples.
- Validated vapor phase nitrogen storage
- Meets regulatory requirements
- Secure, monitored and controlled cryostorage optimised for cell therapy product storage
- Logistics related to clinical trials (product receipt, shipment and delivery), rapid, monitored and controlled.
- Controlled and monitored cold-storage at temperatures such as -20°C and -80°C.
We consult clients from research and industries alike. Our solutions are tailored to your product, trial and target market.
- Navigation of the regulatory landscape
- QMS set up and implementation
- QC advice and implementation
- Critical sample/material control,
- Validation protocol creation and execution,
- Audits
- Gap assessments and recommendations to meet regulatory requirements
Servicing the south east corridor with the highest standard of care.
For close to a decade we have gathered experience. We are in close proximity to large hospitals and have strong clinical networks.
- Facilitation of global clinical trials
- Trial design
- Early phase trial support
- Support with expedited regulatory approvals (TGA CTN Scheme)
- Navigation of regulatory environment
- Manage product storage
- Translation from the lab bench towards a product
We have the capacity to store hundreds of cell therapy products, patient collections and retention samples.
- Validated vapor phase nitrogen storage
- Meets regulatory requirements
- Secure, monitored and controlled cryostorage optimised for cell therapy product storage
- Logistics related to clinical trials (product receipt, shipment and delivery), rapid, monitored and controlled.
- Controlled and monitored cold-storage at temperatures such as -20°C and -80°C.
We consult clients from research and industries alike. Our solutions are tailored to your product, trial and target market.
- Navigation of the regulatory landscape
- QMS set up and implementation
- QC advice and implementation
- Critical sample/material control,
- Validation protocol creation and execution,
- Audits
- Gap assessments and recommendations to meet regulatory requirements
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.
Hudson Institute Cell Therapies – Enabling Advanced Cell and Gene Therapy at Monash Medical Centre
Hudson Institute Cell Therapies (HICT) offers streamlined, accredited access to cell therapy processing services within the Monash Medical Centre Precinct—supporting clinicians with a local, purpose-built facility that reduces logistical complexity and enhances patient care pathways.
We provide clinicians at the Monash Medical Centre Precinct with fast-tracked access to accredited services and facilities, removing logistical challenges and contributing to a more efficient and positive patient experience.
HICT is accredited to receive, store, and distribute human cellular therapy products in alignment with both multi-stage clinical trials and standard-of-care procedures. Our facility is designed to support the evolving needs of cell and gene therapy, providing reliable, compliant infrastructure that integrates closely with hospital workflows.
What distinguishes HICT is our strong commitment to regulatory compliance, risk management, and quality assurance. Every project undergoes thorough evaluation by our dedicated Quality team, ensuring that all processing activities meet the standards set by NATA ISO15189, NPAAC, and the Australian Regulatory Guidelines for Biologicals (ARGB). This ensures a consistently high level of safety, transparency, and reliability across all services.
By offering proximity to clinical teams, a flexible operating model, and strict adherence to regulatory frameworks, HICT plays a critical role in accelerating access to advanced cellular therapies—supporting both research-driven innovation and patient-focused care.”
Hudson Institute Cell Therapies – Enabling Advanced Cell and Gene Therapy at Monash Medical Centre
Hudson Institute Cell Therapies (HICT) offers streamlined, accredited access to cell therapy processing services within the Monash Medical Centre Precinct—supporting clinicians with a local, purpose-built facility that reduces logistical complexity and enhances patient care pathways.
We provide clinicians at the Monash Medical Centre Precinct with fast-tracked access to accredited services and facilities, removing logistical challenges and contributing to a more efficient and positive patient experience.
HICT is accredited to receive, store, and distribute human cellular therapy products in alignment with both multi-stage clinical trials and standard-of-care procedures. Our facility is designed to support the evolving needs of cell and gene therapy, providing reliable, compliant infrastructure that integrates closely with hospital workflows.
What distinguishes HICT is our strong commitment to regulatory compliance, risk management, and quality assurance. Every project undergoes thorough evaluation by our dedicated Quality team, ensuring that all processing activities meet the standards set by NATA ISO15189, NPAAC, and the Australian Regulatory Guidelines for Biologicals (ARGB). This ensures a consistently high level of safety, transparency, and reliability across all services.
By offering proximity to clinical teams, a flexible operating model, and strict adherence to regulatory frameworks, HICT plays a critical role in accelerating access to advanced cellular therapies—supporting both research-driven innovation and patient-focused care.”
Quality Consultation
The HICT Quality Team is expert in the following regulatory standards
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
About Hudson Institute Cell Therapies
Creating seamless interaction between use of technology platforms, research and clinical trials capabilities.
HICT facilitates safe, translational, high quality clinical cell therapy processing and cryopreservation that provides a strong foundation upon which to advance trials. Work undertaken by HICT does so within our Quality Management framework, ensuring consistent accountability and reproducibility while providing clients with confidence in their results.
News
For the first time in Australia, a child has received an infusion of their own umbilical cord blood stem cells to treat cerebral palsy (CP), and Hudson Cell Therapies played a crucial role in making it happen…
Pioneering Australian research, undertaken by a collaboration of Hudson Institute of Medical Research, Monash Health’s Monash Children’s Hospital and The School of Clinical Sciences at Monash University has successfully demonstrated… LEARN MORE >
When unborn babies suffer a stroke, the potential damage can be life-long, so Hudson Institute of Medical Research is aiming to change that using the stem cells found in umbilical cord blood (UCB)… LEARN MORE >
9News exclusive on World-first cord blood trial on baby Chase, who suffered a perinatal stroke is the first baby to go through this trial. LEARN MORE >
For the first time in Australia, a child has received an infusion of their own umbilical cord blood stem cells to treat cerebral palsy (CP), and Hudson Cell Therapies played a crucial role in making it happen…
Pioneering Australian research, undertaken by a collaboration of Hudson Institute of Medical Research, Monash Health’s Monash Children’s Hospital and The School of Clinical Sciences at Monash University has successfully demonstrated…
When unborn babies suffer a stroke, the potential damage can be life-long, so Hudson Institute of Medical Research is aiming to change that using the stem cells found in umbilical cord blood (UCB)…
9News exclusive on World-first cord blood trial on baby Chase, who suffered a perinatal stroke is the first baby to go through this trial