How International Standards Can Help Chinese Biobanks Go Global?

In early September 2025, Zisis Kozlakidis, Director of the Biobank Laboratory at the World Health Organization's International Agency for Research on Cancer (WHO-IARC), and a delegation visited the Biobank at the Hainan International Medical Center (HIMC) at the School of Medicine of Shanghai Jiao Tong University for in-depth discussions on biobank standardization. This visit builds a bridge for Hainan's Free Trade Port medical research to connect with international standards and accelerates the integration of Chinese biobank resources into the global collaborative network.

International Experience: WHO-IARC's Core Standardization Framework

As the global authority on biobanks, the WHO-IARC standardization system is centered on "scientific rigor + safety and compliance," with clear requirements for sample packaging and transportation. Professor Zisis Kozlakidis emphasized, "The UN3373 standard for the transport of biological materials is fundamental to cross-border sample flow and must ensure safety through triple protection."

Among the packaging solutions he recommended, UN3373 specimen bags (Biohazard Specimen Bags) are a key component. The bags must be clearly labeled with the biohazard symbol, and a leak-proof inner membrane and a middle absorbent layer provide dual protection. They must also withstand a 1.8-meter drop test and a 95kPa pressure test to prevent sample leakage. This "clear labeling + enhanced protection" design has been incorporated into the 2025 International Society of Biological and Environmental Repositories (ISBER) Best Practices Guidelines, becoming a universal choice for global cross-border sample transport.

WHO-IARC also prioritizes the flexibility of the standard, introducing a modular approach tailored to regional resource requirements, allowing institutions to implement core requirements such as packaging and temperature control in phases. This model provides a viable path for Chinese specimen repositories to align with international standards.

Local Practice: Hainan Sample Bank's "Standard Implementation + Product Application"

The Hainan International Medical Center Biobank, as the core vehicle for this collaboration, is leveraging the Free Trade Port policy to advance its internationalization efforts. Tong Tianlang, Deputy Director of HIMC, explained that the center has completed the construction of its first 300-square-meter intelligent storage area. UN3373 specimen bags (Biohazard Specimen Bags) are now fully utilized for sample pre-processing and short-distance transportation. "The double-layer, leak-proof design of these Specimen Bags meets our full process needs, from sample collection to cold storage, and also complies with the biohazard sample packaging requirements of the domestic Regulations on Biosafety Management of Pathogen Microbiological Laboratories."

HIMC has already reached a preliminary collaboration with the National University Hospital of Singapore. Using tropical disease samples as a pilot project, they plan to explore new cross-border sample distribution channels through a "international standard packaging + Free Trade Port Express Lane" model. Furthermore, the center is optimizing its sample traceability system through standardized labeling of specimen bags, enabling visual management of the entire process from collection to delivery.

Compliance Comparison: A Path to Bridging Standard Differences

The differences between Chinese and international biological specimen standards primarily focus on packaging testing and approval processes. Domestic standards have stricter temperature control accuracy requirements (±1.5°C), while international standards focus on air pressure simulation testing. UN3373 specimen bags (Biohazard Specimen Bags), compatible with both GB/T 4857.23 and ISO 13408, are crucial for bridging these differences. Their temperature resistance range, covering -20°C to 60°C, accommodates the temperature control requirements of various transportation scenarios.

At the approval level, Hainan is leveraging its pilot Free Trade Port policy to innovate: for projects included in the WHO International Multicenter Study, the export approval process for samples is streamlined, shortening the timeframe to five working days. Furthermore, cross-border transport requires the use of UN3373-compliant specimen bags, ensuring a balance between compliance and efficiency.

During this visit, the two sides finalized three collaborative initiatives: jointly developing sample pretreatment standards for Asian populations, establishing a "fast track" for cross-border sample transportation, and developing training courses on the standardized use of specimen bags.

These initiatives not only promote the internationalization of the Hainan Biobank but also make compliant products such as UN3373 specimen bags (Biohazard Specimen Bags) the "foundational carrier" for the Chinese Biobank to connect globally. As Professor Kozlakidis stated, "The core of standardization is to enable the global flow and sharing of biological resources through unified carriers and processes."