Experts Speak Forum: Implementation of the FAIR Principles in Biobanking Needs Fair Incentives
While the FAIR (Findable, Accessible, Interoperable, and Reusable) principles are primarily concerned with data, samples can also be considered a distinct category of data. In light of these considerations, the FAIR principles represent a major challenge for biobanks, as discussed in detail in two recently published studies. We invited seven experts with diverse backgrounds to share their views on these studies and the FAIR principles in general. The contributions are written from different perspectives, including those from human biobanks operating globally, located in low- or middle-income countries or in high-income countries, as well as those from industrial or environmental biobanks. The last two contributions focused on technical feasibility and the necessary incentives. All authors agreed that while the FAIR principles present a challenge for biobanks, they also offer opportunities. Various useful instruments already exist, and more will follow. The key is to provide meaningful incentives.
Challenges and Opportunities for Collaboration Between Academic Biobanks and Industry: Results of an International Survey of Academic Biobanks
When it comes to collaboration between academic biobanks and the pharmaceutical/biotechnology industry, the criteria for effective collaborations are still unclear. Researchers in industry and academic biobanks can have different incentives and requirements that the other party is often not familiar with. This survey was conducted in an attempt to increase understanding of these fundamental knowledge gaps that may be obstacles to optimal collaboration between academia and industry. There were 53 total respondents. Although this was a global survey, most respondents ( = 29) were from North America, likely reflecting overall investment in research in this region and possibly increased interactions between academia and industry as well. Most respondent academic biobanks collect multiple sample types with most (>90%) collecting both biofluids (including blood) and tissue. Most of the participating academic biobanks were aware that they were not (35%), or only partially (35%), using the full potential of their inventory. One option for increasing utilization rates is by collaborating with industry partners. The main issues when working with industry were perceived to be a combination of challenges including contractual (55%), consent restrictions (45%), timelines (41%), or time pressure (36%). Time taken to put agreements together was also a significant hurdle (54%), together with the industry's administrative requirements (36%). To take advantage of opportunities for joint collaboration, it is essential that the parties involved build trust. The first step is to understand the different requirements and needs of the other party and to establish efficient structures for joint cooperation. This survey has highlighted key areas to be addressed as the next steps for strengthening bonds between academic biobanks and industry partners.
Studies on the Quality and Antioxidant Status of Cryopreserved Pantja Buck Semen Supplemented with Aqueous Extract of Rosemary and Sericin in Tris Extender
Rosemary shrub/plant and Sericin have been documented to show antioxdative properties, however their role in improving post thaw semen quality has not been well established. The present study was conducted to investigate the effect of Rosemary leaves extract and Sericin protein on post-thaw quality of Pantja buck semen. In the first experiment, 32 ejaculates were collected from 4 sexually mature Pantja bucks and pooled to form 8 pooled samples. The pooled samples were evaluated for seminal attributes (sperm motility, viability, morphology, plasma membrane integrity, and acrosomal integrity), status of antioxidative enzymes (superoxide dismutase, catalase, glutathione peroxidase, and glutathione reductase) and lipid-peroxidation (malondialdehyde) of sperm plasma membrane before dilution. In the second experiment, pooled samples were divided into three equal aliquots as group-C (Control), group-R (Rosemary), and group-S (Sericin). Aliquots of group-C were diluted in glycerolated Egg Yolk Tris (EYT) extender, whereas aliquots of group-R and group-S were additionally supplemented with 4.0% v/v Rosemary leaves extract and 0.25% w/v Sericin, respectively, and again examined for the above parameters at the post-dilution, post-equilibration, and post-thawing stages of semen freezing. Significant differences ( < 0.05) were observed in the values of seminal attributes, level of enzymatic antioxidants, and lipid per-oxidation between group C and R and between group C and S at the post-thaw stage of semen freezing. However Sericin was nonsignificantly better than Rosemary in improving post-thaw semen quality. The results of the present study on limited semen samples in Pantja buck demonstrated that compared to the control group, both Rosemary aqueous extract (4%) and Sericin protein (0.25%) as an additive in TRIS extender, showed better cryoprotective effects resulting in improved post-thaw seminal characteristics.
Framing a Biobanking Response to Myrtle Rust in Western Australia
Myrtle rust is a plant disease caused through infection by the fungus and was first detected in Australia in 2010. The disease has spread through New South Wales, Victoria, Queensland, the Northern Territory, and Tasmania. In this short timeframe, myrtle rust has had a devastating impact on many native species in the family Myrtaceae, including several rainforest species that are now at risk of extinction. In 2022, myrtle rust was first detected in the northern part of Western Australia (WA)-the largest state in Australia. WA is home to 2000 Myrtaceae taxa ( 60% of Australia's Myrtaceae diversity), many of which form the dominant component of the vegetation across several ecosystems (e.g., etc.). While modelling suggests that the environmental conditions in WA's north are less conducive to myrtle rust in comparison to the wet, temperate rainforests of the east coast, WA's temperate, Myrtaceae-rich south coast may be climatically suitable. Coupled with the sheer abundance of Myrtaceae species in WA, their high degree of endemism, high proportion of threatened species, and little available information on their susceptibility to myrtle rust, a pre-emptive strategy to conserve germplasm of at-risk species is warranted. This paper highlights the role of germplasm conservation in responding to biosecurity threats such as myrtle rust. With early intervention critical to sourcing healthy and genetically diverse germplasm, we present a prioritized list of genera and species of Myrtaceae in WA to inform strategic, coordinated, and timely conservation actions, along with case studies to illustrate the complementary approaches of seed banking, cryobiotechnology, and tissue culture necessary to conserve germplasm of WA's myrtaceous flora.
Experts Speak Forum: Community Engagement in Research Biobanking
A Review of Regulatory Frameworks for Biobanking in Southeast Asia
Southeast Asian countries are at the forefront of public health pressures due to a confluence of factors such as population growth, urbanization, environmental pollution, and infectious diseases (re)emergence. Therefore, the ability to be able to conduct research addressing local and regional needs is of paramount importance. As such, biobanking activities, the standardized collection of biological samples, and associated data, developed over the past few decades supporting ongoing biomedical and clinical research, as well as surveillance are of critical importance. However, the regulatory landscape of biobanking is not widely understood and reported, which this narrative review aims to address for the ASEAN member states. It is evident that there are specific regulatory arrangements within each ASEAN member state, which though may be sufficient for the current level of operations, are unlikely to support a regional sharing of biological samples, data, and eventually benefits from the conducted research. Additionally, legacy and often-overlapping regulatory frameworks exist, which raise the need of an eventual consolidation under a single framework. Thus, this field requires further study as well as the creation of viable, practical proposals that would allow for biobanking harmonization and thus the exchange of biological samples and data to be achieved regionally, if not further afield.
Quality Assessment of Long-Term Cryopreserved Human Bone-Derived Marrow Mesenchymal Stromal Cell Samples: Experience from the Texas Heart Institute Biorepository and Biospecimen Profiling Core
In biomedical research, biorepositories are pivotal resources that safeguard and supply clinical samples for scientific investigators. Proper long-term cryopreservation conditions are essential to maintain biospecimen quality. In this study, we analyzed the efficacy of sample cryopreservation at the Texas Heart Institute Biorepository and Biospecimen Profiling Core (THI-BRC). Our assessments included a thorough review of internal processes, quality reports, and both internal and external audit outcomes. We examined the integrity of human bone marrow-derived multipotent mesenchymal stromal cells (BM-MSCs) that were cryopreserved for over 5 years. These samples originated from randomly selected clinical trial participants or commercially sourced cell lines. Parameters such as cell viability, DNA and RNA integrity, population doubling time, sterility, and BM-MSC-specific attributes such as surface antigen expression and differentiation potential were studied. BM-MSC samples cryopreserved for ∼6 months served as our control. Our results demonstrated that the 5-year cryopreserved samples maintained their integrity compared with the shorter-term stored control samples. Moreover, THI-BRC has met accreditation agency standards and has not received any repeated deficiencies over 7 years. Collectively, our findings affirm that THI-BRC's biospecimen storage protocols align with accepted standards as confirmed by the quality assessment of long-term stored clinical samples.
Shipment of Glycerolized RBC Segments for Red Cell Concentrate Compatibility Testing
Red cell concentrate (RCC) cryopreservation allows for long-term storage of RCCs with rare phenotypes. Currently, tubing segments are not produced for these frozen units. Pre-transfusion compatibility testing therefore requires thawing and deglycerolization of the whole unit. A study was conducted to demonstrate the feasibility of using segments for compatibility testing, including circumstances where segments would require shipment to a reference laboratory. RCCs produced using the red cell filtration method from citrate-phosphate-dextrose whole blood collections were glycerolized (40%) at day 21 post-collection and segments were generated prior to freezing. Room temperature (RT, 18°C-20°C) or water bath (WB, 37°C) thawing of segments was performed prior to storage at RT or at refrigerated temperatures (cold, 1°C -6°C) for 0, 24, 48, or 72 hours followed by deglycerolization and hemolysis testing. Additional segments were thawed and shipped in temperature-controlled containers at either RT or 1°C -10°C for antibody screening. Hemolysis and RBC recovery results did not show significant differences over the storage period or between thawing and storage conditions. RBC recovery ranged from 46% to 64%. Hemoglobin (Hb) recovery ranged from 56% to 96%; for RT-thawed segments, recovery was significantly higher at 24 hours and lower at 72 hours for RT storage compared with cold storage. WB-thawed, cold-stored segments had higher Hb recoveries at 48 hours. Phenotype assessment was successful for all segments regardless of thawing method or shipping condition. The shipment of thawed segments containing glycerolized red cells is feasible for the purpose of conducting pretransfusion phenotype evaluations or pretransfusion compatibility checks.
Cord Blood Banking in Vietnam: Historical Perspective, Status, and Future Developments 2023
Institutional Conversion to Energy-Efficient Ultra-Low Freezers Decreases Carbon Footprint and Reduces Energy Costs
The storage of biospecimens is a substantial source of greenhouse gas emissions and institutional energy costs. Energy-intensive ultra-low temperature (ULT) freezers used for biospecimen storage are a significant source of carbon emissions. ENERGY STAR-certified ULT freezers have the potential to decrease the carbon footprint. Quantify the impact of an institutional-scale freezer conversion program on carbon emissions and energy costs. A ULT freezer energy use prediction model was developed to identify and replace the most inefficient freezers in the research building for this pilot, and eventually institution-wide. Multiple linear regression factors included the number of years of use, storage volume, and ENERGY STAR certification status. Electrical usage and carbon emissions were quantified before and after replacement with ENERGY STAR models. Logistical methods were developed to decrease the risks of exposure of frozen samples to ambient temperature during content transfers. Institution-wide energy costs were derived by converting electrical burden to electrical costs. Carbon footprint assessment from ULT freezer operation was computed using the U.S. EPA Greenhouse Gas Equivalencies Calculator. The pilot project revealed an annual reduction of 310,493 kilowatt hours of electrical usage, equivalent to 134 metric tons of carbon emissions. Annual electrical costs were reduced by $55,889 resulting in an 8-year payback on the initial investment. Using the pilot results, we modeled the benefit of the freezer exchange across the entire institution. The modeling predicted that conversion of the institution's remaining 1119 conventional ULT freezers to ENERGY STAR models would lower annual electrical usage by 7,911,549 kilowatt hours (3423 metric tons of carbon emissions), resulting in savings of over $1.4 million annually. Our methods make a large-scale initiative to replace energy-inefficient ULT freezers logistically possible, reduce carbon footprint, and demonstrate an attractive return on investment while proactively protecting valuable research materials.
MIBLood-EV: An Online Reporting Tool to Facilitate the Standardized Reporting of Preanalytical Variables and Quality Control of Plasma and Serum to Enhance Rigor and Reproducibility in Liquid Biopsy Research
Pre-analytical variability significantly impacts the reproducibility of liquid biopsy research, which is critical for precision medicine and biomedical research. This report highlights the challenges and variability in the pre-analytical processes of liquid biopsies, especially regarding extracellular vesicles (EVs), which are crucial for diagnostics in oncology. The MIBlood-EV initiative aims to standardize the reporting of pre-analytical variables and the quality control of plasma and serum samples to enhance reproducibility in EV research. By providing a comprehensive and flexible reporting framework, MIBlood-EV seeks to improve the reliability of EV studies and facilitate the development of evidence-based protocols, ultimately advancing the field of liquid biopsy research.
Supplementation of Rooster Semen Extender with Aqueous Extract of for a Long Time Preservation by Low Temperature
The peroxidation of spermatozoa membrane phospholipids is a primary cause of irreversible changes in the preservation of avian semen. To address this issue, the objective of the present study was to assess the potential of extracts in protecting avian spermatozoa during prolonged storage. Gas chromatography-mass spectroscopic techniques were employed to evaluate the bioactive compounds present in the aqueous and ethanolic extracts obtained from the aerial parts and roots of . Semen samples were collected from 16 roosters twice a week and were diluted in Lake's extender containing different concentrations (0, 0.5, and 1 mg/100 mL) of the various extracts. Subsequently, the extended semen samples were cooled and stored at 5°C, and the sperm quality parameters were assessed at 0, 12, 24, and 36 hours of storage. The data from this experiment clearly demonstrate that the addition of nettle root aqueous extracts to the semen diluent, especially at a concentration of 0.5 mg/100 mL, resulted in a significant improvement in various sperm quality parameters. Notably, there were enhancements in total and progressive sperm motilities, viability, fertility, membrane integrity, acrosomal membrane integrity, and a reduction in malondialdehyde production in rooster semen stored for up to 36 hours. Interestingly, the present study reveals that the beneficial effects of the aqueous extracts from different parts of the nettle were supported not only by the conventional manual method but also by the computer-assisted sperm analysis system. This dual confirmation further emphasizes the positive impact of the aqueous extract on various sperm traits during cooled semen preservation. In conclusion, this study highlights the potential of extracts, particularly the aqueous extract from nettle roots at a concentration of 0.5 mg/100 mL, in safeguarding avian spermatozoa during prolonged storage. The significant improvements in various sperm quality parameters and the validation of results through both manual and computer-assisted analysis methods provide strong evidence for the application of extracts in avian breeding programs and artificial insemination practices.
Evaluation of Ethanolic Extract of and Trehalose on Cryopreserved Goat Epididymal Spermatozoa
The purpose of this study, carried out in two experiments, was to investigate the antioxidant effect of in Experiment 1, and trehalose in Experiment 2 in the freezing extender, on the quality of frozen-thawed goat epididymal spermatozoa. Sperm samples were added to based egg-yolk Tris-extender containing experimental treatments. The first experimental treatments included the following: an extender of the control group without additive and extender containing 50, 100, or 150 µg/mL of ethanolic extract (PEE1, PEE2, and PEE3, respectively). Treatments of the second experiment include an extender of the control group without additive, an extender containing 100 mM of trehalose (Tr), an extender containing 100 µg/mL PEE2, and 100 µg/mL PEE2 + 100 mM Tr. The results of the first experiment showed that PEE2 compared with the control group led to a significant decrease ( < 0.05) in malondialdehyde (MDA) concentration. Also, PEE1 and PEE2 treatments resulted in a significant increase ( < 0.05) in motility parameters by computer-assisted sperm analysis, and MDA concentrations decreased significantly ( < 0.05) in all treatments compared with the control group. In general, the results of the present experiment showed that ethanolic extract at the level of 100 µg/mL was effective in improving the quality of frozen-thawed goat epididymal spermatozoa. Also, a combination of ethanolic extract and trehalose can be successful in freezing goat epididymal spermatozoa.
Developing Informed Consent for Academic Hospital-Based Biobank Modeling: An Experience from Indonesia
Informed consent (IC) for biobank practice is vital to ensure that sample collection, storage, and utilization are ethical. However, the standard practices in biobanking in upper-middle-income countries such as Indonesia often rely on specific consent, leading to restricted sample use and ethical concerns. This article describes the development of an IC model that meets ethical standards and yet is acceptable for biobanking practice in an Indonesian academic hospital. We conducted a study involving Universitas Gadjah Mada (UGM) Biobank Unit and the UGM Academic Hospital, Yogyakarta, Indonesia, between 2019 and 2021. The IC development process consisted of four stages: (1) conceptualization, (2) preparation, (3) pilot, and (4) evaluation. These activities were part of a more extensive pilot study for an academic hospital-based biobank (Medical Biobank for Research in Indonesia (MBRIO) study). We conceptualized a broad consent model, consisting of an information sheet, comprehension test, agreement sheet, and exit survey. We tested and revised the broad consent document to ensure readability, trained 10 consenting staff (1 surgeon and 9 nurses), and then piloted the IC procedure on 24 patients with elective surgery. The evaluation showed that patients understood the information objectively and subjectively. Consenting staff considered the broad consent model acceptable for the academic hospital setting and suggested improvements to increase the readability of information sheets and have more trained staff for better coordination. The IC development process and model consent are ethically sufficient, acceptable and feasible to be implemented in academic hospital-based biobanks in Indonesia adjusted to the business processes.
Research Use of Biospecimens from Deceased Individuals: A Call for Greater Regulatory Harmonization
L-Proline as a Cryoprotective Agent for the Preservation of Skin Fibroblasts
Somatic cell biobanking is a promising strategy for developing reproductive techniques. Although cryopreservation, a technique used for creating biobanks, has been performed on , structural and physiological damage to its cells highlight the need to optimize the cryoprotective solution being used. Therefore, the osmoprotective activity of 5 mM L-proline was evaluated as an alternative cryoprotectant for fibroblast conservation. The concentration was defined based on previous studies conducted on mammalian cells. Cells derived from the skin of six individuals were cultured until the fifth passage were cryopreserved under the following treatments: (i) control (non-cryopreserved); (ii) a solution with 10% dimethyl sulfoxide (MeSO), 10% fetal bovine serum (FBS), and 0.2 M sucrose; (iii) a solution with 10% MeSO, 10% FBS, and 5 mM L-proline; and (iv) a solution with 10% MeSO, 10% FBS, 0.2 M sucrose, and 5 mM L-proline. Tests were conducted to analyze cell morphology, viability, metabolism, proliferation, and apoptosis; reactive oxygen species (ROS) levels; and mitochondrial membrane activity (ΔΨm). A reduction in the number of viable cells (72.3% ± 1.2%) was observed in the sucrose-containing group compared to the control (86.7% ± 2.0%) and L-proline (88.4% ± 1.8% and 87.8% ± 2.1%) groups. After apoptotic analysis, a reduction in the number of viable cells was observed in the group with sucrose alone (74.6% ± 4.1%) compared to the control group (88.2% ± 1.1%). The ROS levels (1.03 ± 0.5 and 1.07 ± 0.5, respectively) and ΔΨm values (0.99 ± 0.42 and 1.22 ± 0.73, respectively) observed in the groups with L-proline were similar to that observed in the control group (1.00 ± 0.5 and 1.00 ± 0.4, respectively). Moreover, no difference was observed between groups for cell morphology, metabolism, or proliferation. Thus, L-proline is a cryoprotectant agent that can be used during fibroblast cryopreservation, alone or with sucrose. In addition, we developed an adequate biobank for , whereby stored cells could be used for reproductive techniques.
Assessing Decisional Regret Among Biobank Sample Donors
Large biobanks that link biological specimens with specimen donors' health histories are a critical tool for precision medicine, and many health care institutions have invested significant resources in setting up and building up large collections for this purpose. As biobanks require consented participation from thousands of individual donors, much research has focused on the values and preferences of new and prospective donors who are actively contemplating an invitation to participate in the collection. Few studies, however, have focused on participants' opinions about their biobank participation in the months and years following enrollment. We conducted a survey in a large, established biobank and evaluated participants' levels of decisional regret regarding their decision to enroll in the biobank. We found very low levels of decisional regret among established biobank participants. Multivariable regression analysis found that age, length of time in the biobank, lower educational attainment, inadequate health literacy, and previous invitations to research participation were all significant predictors of elevated regret. Among those with elevated regret, several demographic factors may point to elevated likelihood of decisional regret. More research is needed to identify factors associated with long-term satisfaction with biobank participation and with elevated risk of regret and/or withdrawal from the collection.