Description of basic quality management structure for biobanking and pre-analytical handling of human breastmilk specimens

Task 4.4: Developing standard documents for pre-examination processes for breast milk handling and biobanking activities (M1-M60) (BBMRI, UPPS, CHUT, UOSL, Pfizer, CHUV). Building a ‘Breast Milk Biobank Analysis Center’ requires a comprehensive quality management approach, to secure and control all operations associated with conducting clinical trials, biobanking activities, and downstream analysis procedures at multiple process levels. The partners will develop the basic structure of this quality management system from a set of applicable European and International Standards for biobanking and pre-analytical sample handling (CEN/TS 16835, ISO 20387, ISO 9001, ISO 20186 etc.) and the guideline for good clinical practice E6 (R2), ICH-GCP for the protection of donor rights and safety. SOPs from the project partners and from the literature will be reviewed to verify key processes and methods. The collection, processing steps, processing times, storage temperature, freeze-thaw-cycles and so forth, will be addressed to optimize SOPs to optimal sample quality for subsequent analytical methods. The open structure of the standardization process allows transparency to all involved or interested parties. Building and hosting a BBMRI Technical committee will allow all partners to join guided standardization activities with the aim to develop standardized documents. Regular committee meetings will be initiated and hosted and will take place via web-conferences and/or f2f project meetings. Based upon project partners outcomes, standardization activities will be carried out jointly with the partners within the BBMRI Technical committee, aiming to result in the contribution to, and the preparation of, one or more standard document(s), with the focus on the standardization of the pre-analytical and analytical management of breast milk, based on collection, processing steps, processing times, storage temperature, freeze-thaw-cycles and analytical method for defined intended use. The transformation of research findings into application/product ideas transferred to the market afterwards is also assisted by such standardization activities, as they support the dissemination and implementation of innovative knowledge. With the aim to spread the awareness concerning standardization activities of the project, information about standards and standardization will be provided, e.g. via presentations at conferences and workshops, contribution to journals and scientific publications. The results may also be published in guidelines for the handling of human breast milk. Standardization activities will be provided on the website of Uppsala Biobank.