The global market for biobanks is expected to grow to $131 billion by 2030, which would represent an increase of 89 per cent since 2022. The rise of the industry was something noted recently at the 2023 ABNA Biobanking Conference on the Gold Coast.
Many in the audience were accredited to other Standards, and asked the question as to how easy it would be for a facility to extend its accreditation to include Biobanking AS ISO 20387. The answer is – it’s easier than starting from scratch, given that a number of the criteria are the same, with the relatively new Standard sharing its foundations with the likes of ISO 15189:2022 and ISO/IEC 17025:2017.
Accreditation underpins the process
Accreditation in biobanking is crucial, as research is heavily dependent on accurate and reproduceable results. Without a steadfast procedure and the right steps or processes in place, samples can be compromised or untraceable. This can result in massive impacts on time, resources and costs for biobanking projects. One estimate had irreproducible results costing over $28 billion in wasted research efforts in one year in the US alone.
Biobanking is about knowing your starting material
Accreditation provides assurance that biobanking processes are performed to international standards and that researchers can rely on materials stored and distributed by a biobank.
Towards the end of 2021, Biobanking Victoria (part of Monash University) became the first NATA-accredited biobank in Australia. In 2023, as part of NATA’s assessment by the Asia-Pacific Accreditation Cooperation (APAC), NATA became only the second Accreditation Body globally to be recognised for its biobanking accreditation program.
Key points to remember with ISO 20387
For those considering moving towards an accreditation in the biobanking space these are the things you’ll need to have implemented:
- An established Quality Management System
- Appropriate governance
- Transfer agreement and associated documentation
Sample provenance
If all of these elements are in place, then your pathway to accreditation will be significantly easier.
Bringing together biobanks from six continents next April will be ISBER 2024, this time in Melbourne. The challenges of growing the industry with confidence will be considered under the theme of Dreaming beyond barriers. One such issue is sample integrity which underpins the whole industry. Accreditation can help overcome that barrier and provide the confidence required within the transfer and sample process.
NATA continues to work towards accreditation with a number of laboratories. If you have any questions about whether Biobanking AS ISO 20387 could be the right expanded accreditation program for you, please message our team.
