Biorepository standards and protocols for collecting, processing, and storing human tissues.

Area of Science:

• Biorepository Science
• Human Tissue Banking
• Clinical Data Management

Background:

• Advancements in genomics, proteomics, and metabolomics necessitate high-quality, annotated human biological samples.
• Biorepositories are essential for collecting, processing, preserving, and distributing these valuable specimens.
• The utility of biological samples is directly proportional to the quality and completeness of associated clinical data.

Purpose of the Study:

• To highlight the critical role of well-annotated human biological samples in supporting high-throughput research.
• To outline the essential components and considerations for effective biorepository operations.
• To emphasize the importance of ethical review and regulatory compliance in sample banking.

Main Methods:

• Procurement of both diseased and normal human tissues, often with parallel blood collection.
• Processing, preservation, and distribution of samples according to established protocols.
• Annotation of samples with comprehensive clinical information and maintenance of chain of custody.

Main Results:

• Formalin-fixed paraffin-embedded tissues (FFPET) are common but frozen tissues are optimal for RNA and protein analysis.
• Robust infrastructure, including freezers, monitoring, and security, is vital for long-term frozen tissue storage.
• Alternative storage methods, like filter paper for blood, aid in chain of custody and sample identification.

Conclusions:

• Effective biorepositories require meticulous planning, considering end-user needs and adhering to strict ethical and regulatory guidelines.
• Proper sample annotation and preservation are paramount for maximizing the value of biological specimens in research.
• Collaboration with regulatory bodies like the FDA and organizations such as ISBER ensures best practices in biorepository management.