Within biotechnology, a significant issue limiting translational transfer from basic research to clinical and other applications is the requirement for biobanked biological material and associated data considered appropriate for a particular use.
To address this challenge, an International Standard, ISO 20387 - Biotechnology- General Requirements for Biobanking, was published in 2018. The objective of this standard is to develop systems and processes for planning, maintenance and storage of materials for biobanking, ensuring the "fit for purpose" of the materials and the associated data. This standard is published by ISO – The International Standard Development Organization and developed by ISO Technical Committee (TC) 276 - Biotechnology.
The use of the standard can provide confidence in biobanking services for research and development for life sciences and biotechnology. Having access to biological material and data qualified for research use, in both private and public fields, can contribute to improvements in health and quality of life.
In May 2020, ISO published a new implementation guide for biobanks – ISO TR 22758 – Biotechnology – Biobanking – Implementation guide for ISO 20387. This TR provides invaluable guidance to biobanks on how to implement the requirements of ISO 20387. It expands on selected aspects of ISO 20387 and provides examples for illustration purposes. In particular, the TR expands upon the concept of "fit for purpose" going beyond quality alone to determine suitability of the primary outputs of biobanking. It additionally addresses scope of application or conformity and competency of personnel.
The NSAI national standards committee for biotechnology, NSAI TC 62, has contributed significantly to the development of both ISO 20387 and ISO TR 22758 and endorse the use of these to further improve and standardize biobanking practice nationally. In uncertain times such as the current coronavirus pandemic, standards can provide a necessary framework to ensure the continued operation and sustainability of the biobank sector.
Both ISO publications are available from the NSAI published standard catalogue.
ISO 20387 and its implementation guidance ISO TR 22758 are the first publications of International Standards focussed particularly on biobanking. By committing to implementation of these standards, it is possible to improve levels of trust between all parties involved, including donors, researchers and regulatory bodies. It is anticipated that ISO 20387 and its accompanying Technical Report ISO 22758 will impact positively on future biobanking success globally.
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