Biopreservation and Biobanking

Biobanks are a foundational infrastructure supporting research at scale and contributing to scientific progress. The increasing collection of samples and associated data presents challenges in terms of both physical and digital storage and handling. In North America and Europe health data protection frameworks have been in place for several years, regulating the use of collected personal data, including health care data, as those typically used by human biobanks. Yet, regulatory frameworks for biobanking, particularly in low- and middle-income settings, are highly fragmented, and little is known in this area.

This review focuses on identifying the health-related data protection frameworks in sub-Saharan African countries, as they are relevant to biobanking.

We used complementary literature review approaches to ensure the completeness of our results for biobanking identified as “African,” as well as for “disease-based,” “country-based,” and artificial intelligence–based approaches.

In total, 56 articles were identified and reviewed in full, 31 health-related acts and frameworks relevant to biobanking, and 24 general data protection acts and frameworks from 37 countries. In some countries, such as Kenya and Zambia, these acts were implemented, in some others, they were not. In most cases, as these regulatory frameworks have been recently created and implemented, there are little or no data relating to the impact of their implementation.

Our findings confirm that regulatory frameworks for biobanking in sub-Saharan Africa are still in a consistent period of emergence, in an effort by national governments to address the existing fragmented landscape and support the development of research.

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.

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.

Cryopreservation causes harmful effects on sperm quality due to reactive oxygen species (ROS) overproduction and physical–chemical modifications, resulting in reduced sperm fertility potential. Recently, many studies have shown that adding antioxidants to the cryopreservation medium can markedly reduce these damages. The present study aimed to evaluate the effects of pre-treatment with curcumin at 0, 20, 50, and 100 μM concentrations on frozen-thawed human sperm parameters.

Semen samples from 25 normozoospermic men were collected. Then, each sample was divided into five equal parts: fresh group and frozen-thawed groups, including 0, 20, 50, and 100 μM of curcumin. Pre-cryopreservation and post-thaw sperm motility, morphology, vitality, DNA fragmentation, and ROS levels were investigated.

Cryopreservation significantly reduced sperm quality. A known value of 50 μM curcumin significantly improved sperm progressive motility (18.67 ± 1.12 vs. 11.2 ± 1.24, p < 0.01), vitality (35.50 ± 1.63 vs. 21.83 ± 2.64, p < 0.05), and decreased ROS levels (p < 0.05), 50 μM curcumin also efficiently preserved sperm morphology after thawing (13.55 ± 0.33 vs. 6.56 ± 0.16, p < 0.001). Furthermore, the application of 50 μM curcumin resulted in a reduction in DNA fragmentation, though it did not reach statistical significance (p = 0.08). In contrast, 20 μM curcumin only had a significant impact on progressive motility (15.85 ± 0.7 vs. 11.2 ± 1.24, p < 0.05), whereas, in the 100 μM group, there were no significant differences in any of the measured parameters compared with the control group.

It seems that curcumin ameliorates cryopreservation-induced injury to sperm.

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.