Insight Blog
Best practices and new trends in biological sample management
Since the early days of preclinical and clinical research in pharmaceutical development, scientists have consistently prioritised the preservation of biological samples. These samples are crucial not only for confirming analytical results in case of doubt or in case of loss of backup samples, but also for enabling future research using emerging technologies, such as novel biomarkers, to drive meaningful scientific advancements in healthcare.
WHY QUALITY OF SAMPLE STORAGE MATTERS
Proper storage of biological samples is essential. Beyond regulatory and ethical considerations, research centres, analytical laboratories, biobanks, and clinical investigation sites face increasingly complex challenges related to the management, traceability, and integrity of samples throughout their lifecycle.
Samples must be collected and prepared using appropriate materials and standardised protocols (e.g., smart tubes, microtainers). The final sample types (e.g., PBMCs, specific cell types) are becoming more complex and fragile, requiring careful handling. Staff must be regularly trained on new preparation techniques to ensure the reliability and accuracy of results. In some clinical studies, patients collect their own samples, adding complexity in terms of logistics and privacy compliance. Remote trial locations may also influence sample types and preservation methods (e.g., Dried Blood Spot).
KEY TO ACCURATE SAMPLE IDENTIFICATION
A major challenge is ensuring unambiguous identification of biological samples from the moment of collection, including sufficient information to make each sample unique. Handwritten labels are now obsolete. Technological advances such as pre-printed labels, barcodes, and QR code, requiring specific readers, have become standard. A growing trend is the use of RFID (Radio-Frequency Identification) chips, which enhance traceability and efficiency.
Label materials must also be compatible with transport and storage conditions (e.g., labels that remain readable after storage at -196° C in liquid nitrogen).
To ensure traceability, a robust electronic system compliant with 21 CFR Part 11 is essential. These systems may include commercial LIMS (Laboratory Information Management Systems) that include electronic laboratory notebooks, or custom-built platforms tailored to specific research needs; often allowing greater flexibility and adaptability to meet the requirements imposed by the specific research and associated data. They must provide secure access for sample owners, real-time inventory tracking, as well as detailed location and status data to facilitate retrieval and reporting. This information must be included in the inventory reports, enabling researchersto regain control over the traceability and management of their samples.
PRESERVING SAMPLE INTEGRITY
Storage and transportation conditions must maintain sample integrity to avoid degradation that could compromise research outcomes. Common storage methods include refrigeration and ultra-cryopreservation (-80° C or liquid nitrogen). When stability data is lacking, the precautionary principle applies. For DNA-based analyses, a new trend is sample dehydration, allowing long-term room temperature storage at reduced costs without compromising results.
Storage facilities must be secure - using badges, codes, or facial recognition - with access limited to authorised personnel. Equipment should be clean, clearly identified, and monitored 24/7, with contingency plans in place for malfunctions.
Automation and various technological solutions can significantly improve the efficiency of biological sample management. Depending on the number of samples to be stored and managed, the use of robots can reduce human errors. The decision to automate depends on the balance between installation costs and productivity gains.
For sample transport, it is critical to use experienced carriers who comply with international standards. Packaging must ensure temperature control (e.g., dry shippers) and include monitoring to detect any temperature excursions. Packaging should maintain the required conditions for a validated minimum duration.
Transporting biological samples is a demanding process that combines scientific rigour, regulatory compliance, and logistical expertise. It must adhere to the International Air Transport Association (IATA), the Materials of Trade (MOTs) under CFR 173.6 by road for US and the European Agreement standards concerning the International Carriage of Dangerous Goods by Road (ADR); as biological samples are classified as dangerous goods: Category A (UN2814/UN2900) or Category B (UN3373), each with specific packaging requirements (e.g., triple packaging and compliance testing).
ROLE OF BIOBANKS IN BSM
We see an increased role of biobanks that are specialised in storing samples from patients with specific pathologies. This centralisation allows for the quick provision of extremely valuable material to the scientific community for specific research on this disease.
Handling biological samples must comply with biosafety levels (BSL-1 to BSL-4), requiring appropriate protective measures.
The management of biological samples is subject to strict regulations regarding safety, ethics, and confidentiality. Complying with national and international regulations (e.g.., GDPR) is crucial. Clear SOPs and guidelines help ensure the protection of both biological samples and personal data.
CONCLUSION
Although biological sample management is complex, following best practices and leveraging innovative technologies can significantly improve efficiency and quality. Professionals must be trained in these practices and stay up to date with the new trends to ensure sample integrity and the reliability of research outcomes.
Learn more about the smart strategies Clinigen uses to manage biological samples.