INCREASING REGULATORY OVERSIGHT AND STANDARDIZATION OF BIOBANKS TO MAINTAIN SPECIMEN QUALITY

Abstract

The need for standardization of biobanking practices has been recognized throughout the industry. Current efforts include publications of best practice guidelines and voluntary certification/accreditation programs, however currently no mandatory requirements are imposed. Ensuring that proper collection, handling, cryopreservation, storage, and distribution methods are implemented throughout the specimen life cycle is critical to maintain specimen biomarkers. Data collected from specimens tested in clinical trial assays is used to support safety and efficacy claims made in FDA submissions for new product approvals. By combining the CAP Biorepository Accreditation Program requirements with the ISBER Certified Repository Technician Training Program, an unambiguous set of regulations is developed to ensure standardization of best practices across all regulated biobanks. These standards will be included in the Code of Federal Regulations and enforced by CLIA.