Claudia Carranza, Esmeralda Juárez, Laura E Carreto-Binaghi, Rodolfo L Chávez-Domínguez, Montserrat A García-Ramos, Mercedes Viettri, I A Corona-Galvan, Horacio Zamudio-Meza, Edgar Reyna-Rosas, Milton Nieto-Ponce, Andrea Palencia-Reyes, Carlos Blancas-Ruíz, Martha Torres
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Biobanks constitute a critical infrastructure for biomedical research, as they systematically store biological specimens and databases, which are essential for maximizing utility in clinical investigations and facilitating international collaborative efforts. Most countries lack biobank-specific regulatory frameworks, which limits the ability to implement concurrent initiatives in line with international standards. Integrating quality management systems is essential for ensuring specimen quality and security. In this study, we analyzed the importance of the sample storage conditions and the steps required to transition to a formal biobank. We proposed a guide for doing so in the absence of a regulatory framework, based on the ISO 20387:2018 model, and included an example of successful implementation. We integrated environmental sustainability considerations and inter-institutional networking as a strategy for enhancing operational efficiency. Transforming an internal sample storage system into a formal biobank is a strategic and scientific advancement. It ensures that biological materials are managed with the rigor, transparency, and ethical responsibility required by contemporary biomedical research. By doing so, research institutions strengthen their capacity for innovation and collaboration.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120538"},"PeriodicalIF":2.9000,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Biological sample storage in biomedical research.\",\"authors\":\"Claudia Carranza, Esmeralda Juárez, Laura E Carreto-Binaghi, Rodolfo L Chávez-Domínguez, Montserrat A García-Ramos, Mercedes Viettri, I A Corona-Galvan, Horacio Zamudio-Meza, Edgar Reyna-Rosas, Milton Nieto-Ponce, Andrea Palencia-Reyes, Carlos Blancas-Ruíz, Martha Torres\",\"doi\":\"10.1016/j.cca.2025.120538\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Despite the central role of biological samples in biomedical discovery, many research laboratories operate without robust sample storage systems. This compromises sample integrity, reproducibility, biosafety, and the long-term utility of the data. Implementing structured sample storage policies and infrastructure is crucial for maintaining scientific quality, ensuring regulatory compliance, and promoting responsible research conduct. It would be highly beneficial for any research laboratory to transition from sample storage to the implementation of a formal biobank. Biobanks constitute a critical infrastructure for biomedical research, as they systematically store biological specimens and databases, which are essential for maximizing utility in clinical investigations and facilitating international collaborative efforts. Most countries lack biobank-specific regulatory frameworks, which limits the ability to implement concurrent initiatives in line with international standards. Integrating quality management systems is essential for ensuring specimen quality and security. In this study, we analyzed the importance of the sample storage conditions and the steps required to transition to a formal biobank. We proposed a guide for doing so in the absence of a regulatory framework, based on the ISO 20387:2018 model, and included an example of successful implementation. We integrated environmental sustainability considerations and inter-institutional networking as a strategy for enhancing operational efficiency. Transforming an internal sample storage system into a formal biobank is a strategic and scientific advancement. It ensures that biological materials are managed with the rigor, transparency, and ethical responsibility required by contemporary biomedical research. 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Despite the central role of biological samples in biomedical discovery, many research laboratories operate without robust sample storage systems. This compromises sample integrity, reproducibility, biosafety, and the long-term utility of the data. Implementing structured sample storage policies and infrastructure is crucial for maintaining scientific quality, ensuring regulatory compliance, and promoting responsible research conduct. It would be highly beneficial for any research laboratory to transition from sample storage to the implementation of a formal biobank. Biobanks constitute a critical infrastructure for biomedical research, as they systematically store biological specimens and databases, which are essential for maximizing utility in clinical investigations and facilitating international collaborative efforts. Most countries lack biobank-specific regulatory frameworks, which limits the ability to implement concurrent initiatives in line with international standards. Integrating quality management systems is essential for ensuring specimen quality and security. In this study, we analyzed the importance of the sample storage conditions and the steps required to transition to a formal biobank. We proposed a guide for doing so in the absence of a regulatory framework, based on the ISO 20387:2018 model, and included an example of successful implementation. We integrated environmental sustainability considerations and inter-institutional networking as a strategy for enhancing operational efficiency. Transforming an internal sample storage system into a formal biobank is a strategic and scientific advancement. It ensures that biological materials are managed with the rigor, transparency, and ethical responsibility required by contemporary biomedical research. By doing so, research institutions strengthen their capacity for innovation and collaboration.
期刊介绍:
The Official Journal of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)
Clinica Chimica Acta is a high-quality journal which publishes original Research Communications in the field of clinical chemistry and laboratory medicine, defined as the diagnostic application of chemistry, biochemistry, immunochemistry, biochemical aspects of hematology, toxicology, and molecular biology to the study of human disease in body fluids and cells.
The objective of the journal is to publish novel information leading to a better understanding of biological mechanisms of human diseases, their prevention, diagnosis, and patient management. Reports of an applied clinical character are also welcome. Papers concerned with normal metabolic processes or with constituents of normal cells or body fluids, such as reports of experimental or clinical studies in animals, are only considered when they are clearly and directly relevant to human disease. Evaluation of commercial products have a low priority for publication, unless they are novel or represent a technological breakthrough. Studies dealing with effects of drugs and natural products and studies dealing with the redox status in various diseases are not within the journal''s scope. Development and evaluation of novel analytical methodologies where applicable to diagnostic clinical chemistry and laboratory medicine, including point-of-care testing, and topics on laboratory management and informatics will also be considered. Studies focused on emerging diagnostic technologies and (big) data analysis procedures including digitalization, mobile Health, and artificial Intelligence applied to Laboratory Medicine are also of interest.