The availability of high-quality biological and environmental specimens for research purposes requires the development of standardized methods for collection, long-term storage, retrieval, and distribution of specimens. These practices require the implementation of a Certified Quality System specific for the Biobank (ISBER Biobank Proficiency Testing Program. https://www.isber.org/page/PTGI and BBMRI-ERIC Quality Management Services For Basic and Applied Research. https://www.bbmri-eric.eu/services/quality-management/).
In parallel, the biobank infrastructure needs to be designed and implemented (OECD Best Practice Guidelines for Biological Resource Centres. http://www.oecd-ilibrary.org/science-and-technology/oecd-best-practice-guidelines-for-biological-resource-centres_9789264128767-en; ISO/IEC 9001:2015 “Quality Management Systems requirements”. https://www.iso.org/obp/ui/#iso:std:iso:9001:ed-5:v1:en; ISO 20387:2018, Biotechnology—Biobanking—General requirements for Biobanking. https://www.iso.org/standard/67888.html; and ISO/TC 212 “Clinical Laboratory Testing and in vitro diagnostic test systems”. https://www.iso.org/committee/54916.html) with state-of-the-art technologies, and with the objective to be operative for periods up to 20–30 years. The commitment of the institution is critical to achieving this goal.
The technology which will be implemented (e.g., liquid nitrogen mechanical freezers, processing equipment, etc.) must be selected for present and future needs. Choices between manual and robotized equipment must be made, looking at future requirements, and considering the potential to improve the quality of the biobank. Backup systems (electrical and liquid nitrogen (LN2)), remote back-up freezers, and sufficient space to expand are also mandatory for correct implementation and management of the biobank (OECD Best Practice Guidelines for Biological Resource Centres. http://www.oecd-ilibrary.org/science-and-technology/oecd-best-practice-guidelines-for-biological-resource-centres_9789264128767-en).
In this chapter, we describe the most important aspects of biobank engineering, as complementary to, or integral to, the information included in the international guidelines for design and implementation of a state-of-the-art biobank.
- Biobank engineering
- ISO standard
- Quality management system
- Standard operating procedures
- Biorepository accreditation program
- Cryogenic room
- Process laboratories