Business Details
23 Years
experience
Trusted Cell & Gene Therapy Manufacturing Solutions in Melbourne
Since 2003, Cell Therapies has been a leader in manufacturing cell therapies, ex vivo gene therapies, and regenerative medicine products under stringent GMP standards. With over two decades of experience, we specialize in transforming promising research into scalable, compliant, and commercially viable therapies. Our state-of-the-art facility in Melbourne, Australia, is the only one in the country capable of commercial-scale CAR T-cell production, supporting both autologous and allogeneic therapies. We offer end-to-end solutions, including contract manufacturing, technology transfer, process development, analytical testing, and clinical trial support, ensuring seamless transitions from preclinical to commercial stages. Our globally recognized Quality Management System (QMS) has passed inspections by TGA, FDA, PMDA, and EMA, underscoring our commitment to excellence. Embedded within the Peter MacCallum Cancer Centre, we maintain close ties to clinical investigators and academic scientists, enabling rapid translation of research into patient-ready treatments.Our team of experts, with deep expertise in GMP manufacturing, regulatory compliance, and logistics, ensures reliable delivery of therapies across Australia and the Asia-Pacific region. We prioritize innovation, quality, and collaboration, partnering with biotech firms, pharmaceutical companies, and healthcare institutions to advance the cell and gene therapy sector. Our digital-first approach, including real-time batch visibility and IoT-enabled monitoring, enhances compliance and efficiency. With a focus on ESG frameworks and ISO accreditations, Cell Therapies stands as a low-risk, high-compliance partner dedicated to delivering life-changing therapies to patients worldwide.
Services
Contract Manufacturing
Technology Transfer
Process Development
Analytical Testing
Clinical Trial Support
Quality as a Service
Consulting and Advisory
Cryopreservation & Logistics
Details
- Year established: 2003
Highlights and features
- 20+ years of GMP manufacturing expertise in cell and gene therapies
- Globally recognized Quality Management System (QMS) with TGA, FDA, and EMA compliance
- In-house analytical testing and digital infrastructure for traceability
- Embedded in Australia's premier biomedical precinct for clinical integration
- Asia-Pacific Alliance Model for regulatory and logistical support
Associations and certifications
- TGA
- FDA
- PMDA
- EMA
- ISO 9001
What people say
Expert regulatory knowledge
Reliable logistics
Innovative processes
Strong partnerships
Quality focus
Services
Contract Manufacturing
Cell Therapies provides licensed GMP manufacturing for autologous and allogeneic cell therapies, including CAR T-cells and iPSC derivatives. Our Melbourne facility supports clinical trials and commercial supply with validated processes and global regulatory compliance. We ensure scalability and quality from first-in-human studies to market launch.
Technology Transfer
Our six-stage technology transfer framework ensures efficient onboarding of complex cell therapy programs. With over ten successful transfers in four years, we apply risk-based approaches to maintain comparability and reduce transition risks, supporting global regulatory submissions and commercial scalability.
Analytical Testing
We offer TGA-licensed flow cytometry, ddPCR, ELISA, and sterility testing under GMP compliance. Our services include assay development, validation, and stability testing, ensuring product safety and efficacy for regulatory approval and commercial release.
Clinical Trial Support
Cell Therapies supports clinical trial establishment with regulatory expertise, cryopreservation, and validated logistics. Our integration with Australian hospitals and Asia-Pacific networks ensures timely delivery of therapies while meeting global regulatory standards.
Process Development
Our dedicated PC2/BSL2 laboratory develops scalable, closed-system processes for early-stage and commercial therapies. We focus on cost reduction, automation, and regulatory readiness, leveraging platforms like Cocoon and CliniMACS Prodigy to accelerate time-to-clinic.
People
Dr Bev Menner
CEO
Dr Bev Menner has over 20 years in biopharmaceuticals, with expertise in molecular medicine and strategic partnerships. She leads Cell Therapies' vision to deliver advanced therapies, leveraging her background in cancer research and commercial roles in pharma.
Associate Professor Dominic Wall
CSO
As Co-Founder and CSO, Dominic Wall oversees product accountability under TGA licenses. He specializes in CAR-T cell process development and analytics, combining academic leadership at Peter MacCallum Cancer Centre with industry innovation.
Colin McLean
COO
Colin McLean, with a Masters in Transfusion Medicine, leads operations at Cell Therapies. His 14+ years in GMP environments focus on manufacturing, quality systems, and regulatory compliance, ensuring efficient delivery of advanced therapies.
Questions
What services does Cell Therapies offer?
We provide contract manufacturing, technology transfer, process development, analytical testing, clinical trial support, and quality management consulting for cell and gene therapies.
Where is Cell Therapies located?
Our state-of-the-art facility is in Melbourne, Australia, co-located with the Peter MacCallum Cancer Centre in the Victorian Comprehensive Cancer Centre.
What regulatory accreditations do you hold?
We are TGA-licensed and comply with FDA, PMDA, EMA, and ISO 9001 standards, ensuring global regulatory alignment for our clients.
Do you support international clinical trials?
Yes, our Asia-Pacific Alliance Model and global logistics partnerships enable trial execution across Australia, Asia, Europe, and North America.
How do you ensure product quality?
Our inspection-ready QMS includes in-house testing, digital traceability, and validated processes to meet GMP standards and regulatory requirements.
Can you assist with technology transfer?
Our six-stage technology transfer model reduces risks and timelines, with expertise in comparability studies and regulatory submissions for global markets.
