Addressing the quality challenge of a human biospecimen biobank through the creation of a quality management system

PLOS ONE RESEARCH ARTICLE Addressing the quality challenge of a human biospecimen biobank through the creation of a quality management system Marie-Dominique Servais1☯, Florence Galtier2,3,4☯, Agathe Nouvel4☯, Sandra Rebuffat4☯, Jonas Laget ID4, Anne Géan1, Nicolas Provost1, Frédéric Lorcy5, Valérie Rigau5, Guilhem Couderc6, Philippe Géraud2, David Nocca7‡, Nicolas Builles6‡, Nathalie De Préville1‡, Anne-Dominique Lajoix ID4‡* a1111111111 a1111111111 a1111111111 a1111111111 a1111111111 1 Servier, Suresnes, France, 2 INSERM, Clinical Investigation Center 1411, St Eloi Hospital, University Hospital of Montpellier, Montpellier, France, 3 Department of Endocrinology, Lapeyronie Hospital, University Hospital of Montpellier, Montpellier, France, 4 Biocommunication in Cardio-Metabolism (BC2M), University of Montpellier, Montpellier, France, 5 Biological Resources Center, Anatomy and Cytology Laboratory, University Hospital of Montpellier, Montpellier, France, 6 Biological Resources Center, Tissue Bank, University Hospital of Montpellier, Montpellier, France, 7 Department of Digestive Surgery, University Hospital of Montpellier, Montpellier, France ☯ These authors contributed equally to this work. ‡ DN, NB, NP and ADL also contributed equally to this work. * OPEN ACCESS Citation: Servais M-D, Galtier F, Nouvel A, Rebuffat S, Laget J, Géan A, et al. (2022) Addressing the quality challenge of a human biospecimen biobank through the creation of a quality management system. PLoS ONE 17(12): e0278780. https://doi. org/10.1371/journal.pone.0278780 Editor: Roji Balaji Waghmare, College of Food Technology, Dr. Punjabrao Deshmukh Krishi Vidyapeeth, Akola, INDIA Received: May 4, 2022 Accepted: November 22, 2022 Abstract Background The objective of the COMET (COllection of MEtabolic Tissues) biobank project is to create a high-quality collection of insulin-sensitive tissues (liver, muscle, adipose tissues, and epiploic artery) and blood sample derivatives (plasma, serum, DNA and RNA), collected from 270 grade 2–3 obese patients undergoing bariatric surgery. Relevant data on patient such as clinical/biological characteristics and sample handling are also collected. For this, our aim was to establish a Quality Management System (QMS) to meet the reliability and quality requirements necessary for its scientific exploitation. Published: December 30, 2022 Copyright: © 2022 Servais et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability Statement: All relevant data are within the paper and its Supporting Information files. Funding: SATT AxLR, University of Montpellier, University Hospital of Montpellier, Institut de Recherches Internationales Servier and Institut de Recherche Servier had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Materials and methods The COMET QMS includes: (1) Quality Assurance to standardize all stages of the biobanking process, (2) Quality Controls on samples from the first patients included in order to validate the sample management process and ensure reproducible quality; and 3) “in process” Quality Controls to ensure the reliability of the storage procedures and the stability of the samples over time. Results For serum and plasma, several corrective actions, such as temperature handling and centrifugation conditions, were made to the protocol and led to improvement of the volume and quality of samples. Regarding DNA, all samples evaluated achieved a satisfactory level of purity and integrity and most of them yielded the required DNA quantity. All frozen tissue samples had RNAs of good purity. RNA quality was confirmed by RIN, achieving values in PLOS ONE | https://doi.org/10.1371/journal.pone.0278780 December 30, 2022 1 / 21 PLOS ONE Competing interests: The authors have declared that no competing interests exist. Quality management system in the COMET biobank most cases over 7 and efficient amplification of housekeeping genes by RT-qPCR, with no significant differences among samples from the same tissue type. In the “in process” Quality Controls, DNA, RNA, and histological integrity of tissues showed no differences among samples after different preservation times. Conclusion Quality Control results have made it possible to validate the entire biobank process and confirm the utility of implementing QMS to guarantee the quality of a biospecimen collection. Introduction The development of human tissue biobanks is now considered as an indispensable tool for the progression of biomedical research and the development of new therapeutic strategies in personalized medicine (population stratification, biomarker discovery,. . .) [1]. At present, one of the challenges of human biospecimen biobanks is to provide quality-assured materials as well as accurate and reliable associated data (biospecimen are defined as tissues or blood derivatives removed from the patient). There is a recognized need to develop more standardized and harmonized technical procedures for the constitution of biobanks, especially in terms of biospecimen collection and associated data. In this context, the purpose of the COMET (COllection of MEtabolic Tissues) biobank project [2] is to create a high-quality collection of insulin-sensitive tissues (liver, muscle, adipose tissues and epiploic artery) and blood derivatives (DNA, RNA, plasma and serum) collected from grade 2–3 obese patients (body mass index [BMI] � 35 kg/m2) undergoing bariatric surgery. The overarching goal of this biobank is to promote translational and pharmaceutical research in the field of type 2 diabetes (T2D) and related metabolic disorders. Multiple preanalytical factors can affect the integrity of human biospecimens and may thus impact downstream molecular applications. Surgical resection methods, duration and conditions of transport, time and temperature prior to snap-freezing can lead to metabolic, biochemical, and physical stresses known as warm ischemia [3]MA. These factors can also impact the long-term integrity of samples after several years of storage in the biobank (samples are defined as aliquots of tissues or blood derivatives stored in the biobank). Therefore, the quality of human samples and the traceability of sample-related information must be efficiently standardized by the creation of specific procedures to be applied during the biobanking [4]. In order to achieve this, the COMET biobank constitution process was standardized using a Quality Management System (QMS), with two components: Quality Assurance and Quality Controls. The QMS included quality controls of samples at microscopic, macroscopic and molecular levels and validation of the sample management process on the first patients included in the clinical trial. Quality con (...truncated)