Biopreservation and Biobanking

Biobanks are crucial for clinical biomarker research, but pre-analytical processing can impact sample suitability. Insufficient reporting of pre-analytical methods can lead to invalid conclusions.

This study evaluated the pre-analytical reporting quality in 294 clinical biomarker studies using biobank plasma and serum samples published from 2018 to 2023, based on the Sample PREanalytical Code and the Biospecimen Reporting for Improved Study Quality guidelines.

The analysis revealed frequent incomplete reporting. Key underreported elements included fasting time (reported in 31% of articles), freeze–thaw cycles (22.8%), internal transport (8.5%), and centrifugation settings (20%–35%). Demographic data (96.9%), storage temperatures (81%), and blood tube additives (82.7%) were more consistently reported. No significant correlation was found between reporting quality and journal impact factor.

Our findings highlight the need for standardized pre-analytical reporting to improve research replicability and biomarker study quality.

The College of American Pathologists (CAP) Biorepository Accreditation Program (BAP) was established in 2012 with the goal of providing standardized requirements that ensure high quality for procuring, processing, storing, distributing, and computerizing information of biospecimens for scientific investigations. CAP BAP was the first biorepository accreditation program, and, since the program started in 2012, the world’s second biorepository accreditation standard was issued by the International Organization for Standardization (ISO) as ISO 20387 in 2018. CAP BAP serves as an interface between several programs and draws best practices from renowned organizations. This elective program is based on a peer-inspection model to ensure that the inspectors have proper expertise and to promote educational efforts through information sharing. On-site inspections occur every 2 years, like other CAP Accreditation Programs, with an interim self-inspection in the off year. The program compliance is assessed based on CAP Accreditation Checklists, which are regularly revised.

This article reviews the accomplishments of the first 10 years of the CAP Biorepository Accreditation Program.

As of December 2024, 104 biorepositories are CAP BAP accredited, which increased from 53 accredited biorepositories in 2018. Accreditation of 10 additional biorepositories is underway. A total of 88 inspections were completed between January 2017 and December 2022; 16 were initial inspections and 72 were reinspections. Deficiencies, defined as insufficient or lack of evidence of compliance with a checklist item, were mainly related to equipment/instrumentation (24%), quality management (15%), safety (14%), information technology (13%), personnel (13%), specimen handling and quality control (9%), facilities (6%), and regulatory (6%) issues. The proportion of deficiencies between categories was like the first 5 years.

The increased number of accredited biorepositories, in both academic and commercial settings, highlights the continued success of the program and its applicability to maintaining high standards for biorepositories.

The German Biobank Node (GBN) coordinates the national network of academic biobanks in Germany; the German Biobank Alliance (GBA). At the beginning of 2025, the GBA consisted of 42 biobanks. With an upcoming strategic reorientation, the GBN/GBA was interested in understanding the perspectives of their community to ensure that strategic decisions were aligned with their needs and interests.

An online survey with a cross-sectional design was conducted with the GBA community, targeting mostly first-line management of GBA biobanks. The invitation to the survey was sent via an internal GBA mailing list. It addressed primarily satisfaction with GBN/GBA services, organization of and collaboration within GBN/GBA, and expectations/wishes for the future. Responses were analyzed using descriptive statistics and qualitative content analysis.

Participants generally considered being part of GBA to be important to very important. They emphasized the opportunity to network and exchange with colleagues as particularly helpful, but also training opportunities and quality management (QM) tools provided. In terms of organization, they found that the benefits of cooperating within GBA largely outweighed efforts and that opportunities to participate in processes were adequate. However, they also identified areas for improvement, for example, in the provision of information on how to join or establish working groups. In terms of relevant future topics, participants identified lobbying, networking within and outside GBA, training, and QM as particularly important priorities for GBN/GBA, as well as securing funding and strengthening local cooperation for individual biobanks.

The findings have informed the strategic development of GBN/GBA, with QM, education, and networking being the top future priorities. In terms of networking, the GBN/GBA has emphasized the importance of making the perspective of the community heard in other national networks. How to address sustainable funding remains an open question.

Ethical research recruitment relies on effective informed consent. We sought feedback and acceptance from users regarding an interactive, multimedia, electronic consent (e-consent) platform for recruitment of research participants to the BC Children’s Hospital BioBank (BCCHB). We aimed to enhance user experience when considering research participation and documenting consent decisions through the modality of an e-consent.

A prototype e-consent was developed and end-user opinions regarding content, visuals, user satisfaction, and electronic consent/assent practices were obtained from children, teens, and adults via an online survey and focus groups. A finalized e-consent was submitted for research ethics board (REB) approval.

All age groups rated the description of information, images, and formatting in the e-consent as highly favorable. Teens and adults preferred online (38% and 42%) rather than paper-based (17% and 16%) consent, while children expressed no preference. Majority of children (100%), teens (92%), and adults (98%) agreed or strongly agreed that they understood all the information given during the online consent process. No significant differences were found in survey responses between age groups. Adult and teen focus groups suggested improvements in formatting and addition of features to further clarify terms like “ongoing donation” and “privacy measures.” All ages preferred the ability to complete the e-consent independently, with optional assistance from research staff. The e-consent received REB approval and was implemented for BCCHB recruitment.

An e-consent was developed and its modality was successfully accepted by end-users from several age groups, including children and teens, for use in pediatric biobanking. This method may potentially improve the process of completing research consent, particularly with adolescents.

Biorepositories facilitate research and clinical studies in many settings. Modern biobanks use state-of-the art storage methods and low temperatures, while many older collections of biospecimens have been stored at less optimal temperatures. The Janus Serum Bank Cohort in Norway holds over 700,000 serum samples collected decades ago and stored at −25°C. To obtain insights in the stability of serum components at −25°C over prolonged times, we performed 7 measurements for increasing storage time up to 108 months for a panel of 15 serum components.

A selection of analytes (proteins, an enzyme, electrolytes, small molecules, hormones, lipids, and a vitamin) were measured in serum from 40 anonymous donors. The serum components were measured in fresh samples and after 3, 6, 12, 24, 36, 72, and 108 months in storage at −25°C. We tested for variations using analysis of variance and paired sample t-tests and performed trend analyses for these serum component levels against time.

All measured serum components showed differences in values for at least one of the timepoints. Trend analyses identified significantly decreasing levels for nine components, whereas four components showed significantly increasing levels. Two components did not show significant trends.

Storage of serum at −25°C may result in changes in serum analyte levels over time. We cannot exclude that batch effects of assaying kits; laboratory instrument changes and standards contributed to the observed differences. To mitigate the influence of increasing storage time, storage time should be used as matching criteria for control samples included in research projects.

This study aimed to systematically map the literature on saliva collection, processing, and storage methods for biobanking purposes, identifying current practices and gaps in standardization.

A systematic search was conducted in five electronic databases and gray literature. Original research articles reporting cross-sectional and longitudinal studies using saliva for biobanking, as well as reports and protocols for biobank establishment, were included. The review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines, with two reviewers independently assessing eligibility and extracting data.

A total of 50 articles were included, revealing that most studies were reports on biobank establishment (38%), followed by longitudinal studies (28%), protocols (20%), and cross-sectional studies (14%). Saliva collection methods varied, with commercial kits being the most reported (40%), followed by sterile tubes (22%). While 64% of studies described processing methods and 78% reported storage methods, significant gaps in reporting were noted. Unstimulated saliva was the most commonly collected sample type (38%), and most studies focused on adult participants (46%), often with disease conditions (36%). However, many studies did not provide sufficient details on collection methods, processing techniques, storage conditions, or participant demographics.

This review highlights the urgent need for standardized protocols in saliva biobanking to ensure consistency, reliability, and reproducibility in diagnostic research. The lack of uniformity in methodologies across studies limits the potential of saliva biobanks as a resource for identifying biomarkers of systemic and oral diseases. Establishing harmonized guidelines will enhance international collaboration, enable robust analyses, and maximize the utility of saliva in advancing personalized medicine and public health.