What Is Biobanking of Biological Material?

Biobanking refers to the systematic and controlled processes of collecting, labeling, storing, and distributing biological samples. It also involves the associated clinical and operational data—in compliance with ISO 20387 and ISO 17025. Biobanked samples are used in clinical trials, IVD test validation, PMCF surveillance, and the development of new medical devices.

Why Is Biobanking Essential in Clinical Trials?

Biobanking allows for comparative analysis, historical data verification, and long-term studies without requiring repeated patient recruitment. It is crucial for IVD performance evaluation, PMCF projects, and studies supporting clinical evaluation of devices. Samples are also used to verify the effectiveness of new diagnostic technologies under IVDR.

Types of Biological Samples Suitable for Biobanking

  • Whole blood, serum, plasma
  • Saliva, urine, nasopharyngeal swabs
  • Tissue samples (biopsies, cytology)
  • PBMCs, DNA, RNA, microbiome

The sample type must match the study goals and intended use of the device or IVD test.

Sample Collection and Storage Protocols

Collection is performed using validated SOPs by trained medical personnel. Each sample is pseudonymized, labeled, and registered in a LIMS system. Storage at −80°C or in liquid nitrogen tanks must meet ISO 17025 standards, with temperature control, power backup, and access restrictions in place.

Storing biological material requires informed consent compliant with GCP, GDPR, and MDR guidelines. Every collection and storage process must be approved by an ethics committee. Participants retain the right to withdraw consent at any time.

Data Privacy and Personal Information Protection

Samples are pseudonymized, and identifying data is stored separately and only accessible to authorized personnel. Biobanks must enforce GDPR-compliant data protection policies and adhere to national healthcare regulations.

Applicable Quality Standards in Biobanking

  • ISO 20387 – Biobank infrastructure standard
  • ISO 17025 – Testing laboratory competence
  • ISO 15189 – Medical laboratory quality
  • ISO 20916 – IVD clinical studies

Additional requirements include method validation, storage SOPs, QA systems, and internal/external audits.

Types of Biobanks in Clinical Research

  • Academic – publicly funded, supporting translational research
  • Commercial – serving industry-sponsored studies
  • Hospital-based – integrated with clinical practice and labs

For medical device and IVD studies, commercial and academic biobanks with QMS and IVDR/MDR compliance are recommended.

Biobanking Risks and Mitigation Strategies

  • Sample degradation due to unstable storage
  • Labeling errors or lack of traceability
  • Privacy breaches or outdated consents

Mitigation includes using eLIMS, validated SOPs, alarm systems, and EQMS-based quality management.

When Is Biobanking Not Required?

Biobanking is not necessary in studies that do not collect biological material (e.g., observational PMCF or survey-based studies). The decision must be documented in the clinical study protocol with justification.

Required Documentation and Procedures

  • SOPs for sample collection, transport, and disposal
  • Informed consent forms detailing sample usage
  • eLIMS sample management systems
  • GDPR protocol and contingency plans
  • Documentation for notified bodies and NCAs
  • EU and US legal frameworks for biobanking

In the EU, MDR 2017/745, IVDR 2017/746, GDPR, and EMA guidelines apply. In the US, regulations include FDA, HIPAA, and NIH standards. Both jurisdictions require informed consent, quality control, ethical compliance, and interoperable data systems.

How Pure Clinical Supports Biobanking

Pure Clinical provides comprehensive support to clinical and IVD sponsors for designing, implementing, and overseeing biobanking processes:

  • Process design in compliance with IVDR, MDR, and ISO standards
  • Complete documentation package (SOPs, ICFs, LIMS, GDPR protocols)
  • Infrastructure and procedural audit for international standards
  • Training for staff including EUDAMED and notified body compliance
  • Oversight of biobank readiness for inspection and certification audits

With global project experience, we ensure biobanking compliance with both EU and FDA requirements for legal and operational safety.

FAQ

Is international sharing of biobank samples (e.g., between the EU and the US) possible?

Yes, but it requires strict compliance with data protection (GDPR, HIPAA), ethical approvals, and transport logistics. Ethical consent and material transfer must be notified to relevant authorities. Biobanks must implement Material Transfer Agreements (MTAs) to ensure compliance with IVDR and FDA regulations.

What is the significance of eLIMS interoperability during a notified body audit?

eLIMS interoperability allows notified bodies direct access to full sample documentation—from collection to analysis and disposal. Lack of interoperability may result in a major finding, especially if it compromises sample traceability or prevents real-time access to operational data.

Can a biobank be deemed non-compliant if it follows only national standards but not ISO?

Yes – compliance with ISO 20387 and 17025 is considered the international benchmark, especially for IVDR-aligned IVD certification. A biobank relying solely on national guidelines may fail to meet interoperability and auditability requirements expected by notified bodies, potentially leading to sample exclusion or repeat collection.

How can biobanking support the development of artificial intelligence in diagnostics?

Biobanks with biologic samples linked to well-characterized clinical data provide valuable training datasets for AI algorithms. Machine learning models can be validated on historical biobank samples, accelerating the development of clinical decision support systems and predictive diagnostics tools.