ISO 21899, a new biobanking standard to which IBBL contributed extensively, was officially published in June 2020. The norm sets out the general requirements for the validation and verification of processing methods for biological material in biobanks, and will act as a complementary standard to ISO 20387 (General requirements for biobanking).
Many biobanks perform biospecimen processing activities to isolate specific components of interest from the collected biological samples, to be used for biomedical research purposes. These processing methods include DNA, RNA and protein extractions from a variety of samples, such as blood, tissue, seeds, bacteria or other biological materials. In order to ensure the good quality and fitness for purpose of the resulting processing outputs for their intended downstream use, processing methods need to be validated and their outputs annotated and qualified.
In this context, the new ISO 21899 was developed by Working Group 2 of the ISO technical committee 276 ‘Biotechnology’, to define the specific requirements for the validation of processing methods, with the aim of assisting biobank laboratories in performing sample processing. IBBL’s Dr Fay Betsou contributed significantly to the elaboration of the norm, which was published in June 2020.
“We are really pleased to have represented Luxembourg’s contribution in the development of ISO 21899. The new standard strengthens the quality management system of any biobank laboratory performing the processing of biological materials, giving more credibility to the organisation. In addition, ISO 21899 complements ISO 20387, originally published in 2018, further reinforcing the progressive standardisation of biobanking activities at the international level”, comments Dr Betsou.
ISO 21899:2020 can be accessed here.