A biobank is a biorepository that accepts, processes, stores and distributes biospecimens and associated data for use in research and clinical care. Human biospecimens can provide a bridge between emerging molecular information and clinical information, by enabling researchers to study the molecular characteristics of actual disease, and then correlating those patterns with what is known about the clinical progression of the disease. Specifically, human biospecimens can be used to:
- Identify and validate drug targets
- Identify disease mechanisms
- Develop screening tests for “biomarkers” associated with certain sub-types of a disease
- Group patients based on their genetic characteristics and likelihood of positive response, for testing of new drugs
- Group patients based on the “biomarkers” of their disease to determine which treatment is appropriate
- Biological specimen collected in-situ from the patient within the specific biologic context
- Ethically consented, right sample with the right annotation collected, stored in a controlled environment for secure temperature safe shipment
- Intervention via medical/surgical procedures or drugs to change the biologic context of the specimen to understand resultant dynamic changes in the molecular profiles within the specimen.
- Clearly defined study objectives among intended target population and demographic profile must guide the procedures, with alignment across all stakeholders. Right testing conducted to reach the desired result.
- Adherence to consistency and best practice methods critical for maintaining the highest sample integrity
- Unique identifier labeling, preferably 2D-barcoded sample tubes
- Examples of preparation variables introduced prior to and during biological stabilization of the specimen include time at room temperature, temperature of the room, type of fixative, time in fixative, method and rate of freezing, and size of specimen aliquots
- Success factors based on downstream application include: material to collect, preservative to use, processing method and derivatives required
- The storage temperature and duration may impact specimen quality. Progressive dehydration, desiccation, or oxidation may occur.
- When choosing the right storage environment it is important to consider labware/container, temperature, time and expected retrieval needs for downstream assays.
- Variations in transport conditions may cause alterations in the specimen. Those who package and transport the specimens and those who receive and deliver the samples to individual investigators all contribute to variation.
- Collection and shipping kits are tailored to ensure consistency and reproducibility with full traceability of each component, controlled traceable manufacturing process, tested to ensure temperature conformance for expected transit duration.
- Different methods of analysis for various classes of biomolecules may be variably affected by any of the factors above. Even with a single analytic method, each individual investigator and technician involved in the specimen analysis may contribute to analysis variation.
- To avoid analysis variation, establish baseline sample characterization, integrate biomarker results and quality checks for test and controls. All pre-analytical variables, accessibility rules, and timely information should be shared with research collaborators.