Cryogenic Storage for Cell & Gene Therapies: Meeting Australia’s Regulatory Demands
As cell and gene therapies (CGTs) advance from research to commercialisation, ensuring safe, stable, and compliant cryogenic storage becomes a critical component of the clinical and commercial supply chain. These sensitive, often irreplaceable biological products demand uncompromising care, especially within the stringent Australian regulatory environment. Cryosite has emerged as a trusted partner for CGT developers, biotechs, and clinical sponsors by providing purpose-built infrastructure that supports liquid nitrogen storage, 24/7 monitoring, and full compliance with Australian standards like Australian cGMP for Human Blood, Tissues and Cell Therapies and PIC/S GMP.
Why Cryogenic Storage Is Critical in Cell & Gene Therapy
Unlike traditional pharmaceuticals, cell and gene therapies consist of living cells or genetic material that must be kept at ultra-low or cryogenic temperatures—often as low as -150°C or below—to preserve viability. Even brief temperature excursions can damage the product, compromise efficacy, or lead to regulatory non-compliance.
Key reasons cryogenic storage is essential include:
- Cell viability: Cryopreserved cells must remain biologically active and unaltered.
- Chain of identity and custody: CGTs are frequently autologous, meaning the product must be matched precisely to the patient.
- Limited shelf life post-thaw: Once thawed, CGTs typically have hours—not days—of usability.
This level of sensitivity makes cryogenic storage not just a logistics task, but a mission-critical responsibility.
Cryosite’s Cryogenic Infrastructure and Capabilities
Cryosite is one of Australia’s most experienced providers of secure biological data storage and cryogenic storage solutions. We support clients with:
- Liquid nitrogen storage: Ultra-low temperature environments suitable for cell and gene therapies, stem cells, and other biologics.
- Redundant safety systems: Including temperature alarms, remote telemetry, and 24/7 environmental monitoring.
- Validated storage-freezers and tanks: Designed for long-term stability at cryogenic temperatures, available through our Freezer Storage Containers Australia services.
- Chain of custody traceability: Every product is barcoded and tracked across our secure facilities.
- Dedicated storage for Cell & Gene Therapies: Learn more about our Cell and Gene Therapy Storage capabilities.
This infrastructure is backed by robust SOPs, disaster recovery planning, and trained personnel who understand the unique needs of CGT clients.
Regulatory Compliance: GMP and Beyond
Cryosite ensures full alignment with this and other key standards:
- Australian cGMP for Human Blood, Tissues and Cell therapies: Covers storage, labelling, and traceability for human blood, cell and tissue therapies. Learn more
- PIC/S GMP: Covers storage, labelling and traceability of biological products classified as medicines — those that are highly processed, recombinant, or genetically modified.
- Client-specific protocols: Our team works with sponsors and CROs to implement customised handling, labelling, and documentation processes.
Through rigorous internal audits and transparent reporting, Cryosite provides assurance to biotech companies scaling in Australia that their materials are managed to the highest standards.
Partnering with Cryosite: Trusted by Australia’s Biotech Community
For companies developing cutting-edge therapies, scaling in Australia means finding a logistics partner that understands both regulatory nuance and scientific complexity.
Cryosite offers:
- Deep experience in clinical trial packaging services and biological handling
- Secure, long-term solutions for cellbank storage needs
- Proven performance in supporting local and international trials
- A collaborative, transparent approach to client partnerships
You can explore our full suite of Biological Storage Services or get to know our team and infrastructure to see why we’re a preferred partner for Australia’s cell and gene therapy innovators.
Conclusion: Cryogenic Confidence with Cryosite When every degree matters—and every sample could change a life—trust Cryosite to deliver precision, compliance, and peace of mind. From liquid nitrogen storage to regulatory-aligned protocols, we provide the infrastructure Australia’s CGT landscape needs.
Have a question? Contact Cryosite today