Part One of our Protecting Complete Chain of Custody Series
As key components of the research ecosystem, biobanks share a vital function and critical responsibility in the protection of biospecimens. They are centralized members in the chain of custody for samples, and as such, have an impact on both upstream and downstream portions of the molecular biologist’s workflow. This blog series will examine current and foreseen challenges for biobanks, as well as the systems and practices that mitigate these challenges.
What does a biobank do?
Storage and access to biospecimens are necessary for research and testing labs throughout academia and biotech/pharma. Biobanks store biological materials and provide access through physical delivery of samples or delivery of sample data, often processed in a clinical lab associated with the biobank. These functions are valuable at multiple levels in the continuum of research and industrial applications, including:
- Biospecimen library: Biobanks help establish reference ranges for new biomarkers based on the extensive biospecimen library spanning different population groups.
- Data source: For researchers in biomarker discovery, these biospecimens are a source of accurate pre-analytical data, identity data, and clinical endpoint information to support experimental planning.
- Validation: After discovery, industry scientists must validate their experimental findings against qualified samples based on discovery efforts.
- Reference: Reference samples for validation of methods, equipment performance verification, and method comparisons are shipped from biobanks.
What are some biobanking challenges?
The primary source of concern for biobanks is the biospecimens they handle. These samples can experience adverse quality events throughout their lifecycle. It is critical to understand how quality control fits into this whole process of planning your study, collecting and transporting samples at the right temperature and timeline, processing and storing samples, retrieving when needed, and disposing after the retention period.
Diligent regulation and harmonization of standards and practices around these three stages (collection, extraction, storage) reduces adverse quality events by decreasing the variance that can occur during each stage. Some of the questions that should be answered to align with best practices include:
- How should I collect primary samples to ensure maximal use?
- Is there a storage format or temperature that will work best with my logistics and storage infrastructure?
- What type of processing will improve quality and yield of extraction?
- Can I take steps to safeguard my primary or precious sample in storage?
- How should materials and data be distributed to ensure preservation of sample resources?
Summary
Biobanks operate as important sources of both biospecimen samples and data. Whether a researcher needs to identify a biomarker, or validate new clinical protocols, the biobank plays a central role in chain of custody. Regulation and harmonization of standards and observation of best practices overcome challenges that biobanks face throughout their sample lifecycles, but there are important questions in the details of compliance. Answering these questions effectively ensures prolonged protection of samples and high-quality data by reducing adverse temporal and batch effects.
While these questions may seem difficult to answer, the next posts in our blog series will bring together the resources and knowledge of industry expertise to do just that.
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