Biospecimens are biological materials such as urine, blood, tissues, cells, DNA, RNA, that are derived from humans, animals, or plants. Biospecimens are being collected and stored for a long time now to support clinical and research activities. A biorepository is a facility that collects, processes, and stores biospecimens.
Biospecimens from humans are stored and the associated patient information (for example, their medical history, social history, demographic details) are recorded to study a disease, develop a treatment plan, investigate the efficacy of drugs administered, or discover disease biomarkers. Hence, the purpose of establishing a biorepository is to make samples and associated data available to investigators. Biorepositories storing human samples are usually termed as biobanks. With the advancement of modern research and technology, biobanks have become an indispensable resource for research and the rapid development of precision medicine.
Types and Uses of Biorepositories
- Hospital-based biorepositories that support research by biomarker validation.
- Biorepositories that are fully integrated with patient registries.
- Biorepositories that identify genetic clues to help in therapeutic development.
- Disease-focused biorepositories that majorly focus on understanding specific habits and practices.
- Single & multiple study biorepositories that are developed to support a single study or multiple research studies.
- Population-based biorepositories that help in improving the prevention, diagnosis, and treatment of serious diseases prevalent in certain regions.
Framework for Working in a Biorepository
- HIPAA: A biorepository must follow HIPAA guidelines (Health Insurance Portability and Accountability Act) to safeguard patient privacy.
- Informed Consent: Biorepositories store human biospecimens, hence it is required that the consent form is signed by the specimen donors as they have full right to withdraw authorization from using their samples.
- Sample Custody: The custody of samples remains with the researcher who collected them or the biospecimen regulatory body.
- Access to Biological Specimens: Biorepositories should maintain a read-only audit trail to regulate the internal or external transfer of samples, including access to compliant logs with FDA standards for records.
Operations of a Biorepository
- Collection: Samples are accessioned in this step by scanning barcodes with a barcode scanner. The sample information is then entered into a Biobanking LIMS.
- Processing: This step usually involves sample preparation for long term storage and also helps in reducing variations due to sample handling.
- Storage: This step involves storing samples in boxes that are in turn stored in temperature-controlled freezers depending on the storage requirements.
- Distribution: This step involves retrieving samples from the storage for shipment to researchers.
Standard Operating Procedures (SOPs)
The methods of collection, processing, storage, and distribution of samples must be standardized to maintain high-quality samples that are fit for research.
SOPs help biorepository personnel follow standard operating procedures for various biorepository activities.
SOPs can also help to provide minute information about the processes and storage methods that assure the quality of biospecimens. This ensures minimum variations in samples and assures their integrity.
Both the terms, biobanks and biorepositories, are often used interchangeably. However, it is important to differentiate between the two as biobanks store human samples and biorepositories carry samples of all living organisms including humans.