Biopreservation and Biobanking

Publisher: Mary Ann Liebert


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Mary Ann Liebert

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Publications in this journal

  • Biopreservation and Biobanking 10/2014;
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    ABSTRACT: In the last decade, many disease-focused foundations and patient advocacy organizations that support biomedical research have created patient registries and biobanks. This article reviews the motivations behind the creation of those biobanks and how they are different from biobanks sponsored by government or industry. It also discusses some of the different funding models being employed by these organizations. Finally, it highlights some of the unique challenges faced by disease-focused foundations and advocacy organizations that sponsor biobanks, and how they are overcoming those challenges to achieve both financial and operational sustainability.
    Biopreservation and Biobanking 10/2014;
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    ABSTRACT: The Beaumont Health System BioBank was established in 2008, not only to leverage the potential to collect biospecimens for translational research, but to undertake such research in a seamless facility that combined high quality biobanking with state-of-the-art laboratory platforms geared towards biospecimen-based research. This report describes the challenge of sustaining a hospital-based biobank with an operating budget exceeding $1,000,000 in a financial climate that favors short-term fiscal goals rather than long-term scientific ambitions. Some of the key areas that are discussed include grants, philanthropy, accreditation, process improvement and commercialization of samples and services. We conclude that grants are not a feasible avenue, in our case, to support a biobank and that philanthropy and commercialization represent the best options for external funding to support stalling internal support, in order to sustain the operations of the BioBank.
    Biopreservation and Biobanking 10/2014;
  • Biopreservation and Biobanking 10/2014;
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    ABSTRACT: Biorepositories, the coordinating hubs for the collection and annotation of biospecimens, are under increasing financial pressure and are challenged to remain sustainable. To gain a better understanding of the current funding situation for Canadian biorepositories and the relative contributions they receive from different funding sources, the Canadian Tumour Repository Network (CTRNet) conducted two surveys. The first survey targeted CTRNet's six main nodes to ascertain the relative funding sources and levels of user fees. The second survey was targeted to a broader range of biorepositories (n=45) to ascertain business practices in application of user fees. The results show that >70% of Canadian biorepositories apply user fees and that the majority apply differential fees to different user groups (academic vs. industry, local vs. international). However, user fees typically comprise only 6% of overall operational budgets. We conclude that while strategies to drive up user fee levels need to be implemented, it is essential for the many stakeholders in the biomedical health research sector to consider this issue in order to ensure the ongoing availability of research biospecimens and data that are standardized, high-quality, and that are therefore capable of meeting research needs.
    Biopreservation and Biobanking 10/2014;
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    ABSTRACT: Background: Formal validation of methods for biospecimen processing in the context of accreditation in laboratories and biobanks is lacking. A protocol for processing of a biospecimen (urine) was validated for fitness-for-purpose in terms of key downstream endpoints. Methods: Urine processing was optimized for centrifugation conditions on the basis of microparticle counts at room temperature (RT) and at 4°C. The optimal protocol was validated for performance (microparticle counts), and for reproducibility and robustness for centrifugation temperature (4°C vs. RT) and brake speed (soft, medium, hard). Acceptance criteria were based on microparticle counts, cystatin C and creatinine concentrations, and the metabolomic profile. Results: The optimal protocol was a 20-min, 12,000 g centrifugation at 4°C, and was validated for urine collection in terms of microparticle counts. All reproducibility acceptance criteria were met. The protocol was robust for centrifugation at 4°C versus RT for all parameters. The protocol was considered robust overall in terms of brake speeds, although a hard brake gave significantly fewer microparticles than a soft brake. Conclusions: We validated a urine processing method suitable for downstream proteomic and metabolomic applications. Temperature and brake speed can influence analytic results, with 4°C and high brake speed considered optimal. Laboratories and biobanks should ensure these conditions are systematically recorded in the scope of accreditation.
    Biopreservation and Biobanking 10/2014;
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    ABSTRACT: The purpose of the present study was to evaluate the short-term storage of meta-genomic DNA from native oral biofilms on FTA(®) paper.
    Biopreservation and Biobanking 10/2014; 12(5):337-42.
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    ABSTRACT: Uppsala Biobank is the joint and only biobank organization of the two principals, Uppsala University and Uppsala University Hospital. Biobanks are required to have updated registries on sample collection composition and management in order to fulfill legal regulations. We report here the results from the first comprehensive and overall analysis of the 131 research sample collections organized in the biobank. The results show that the median of the number of samples in the collections was 700 and that the number of samples varied from less than 500 to over one million. Blood samples, such as whole blood, serum, and plasma, were included in the vast majority, 84.0%, of the research sample collections. Also, as much as 95.5% of the newly collected samples within healthcare included blood samples, which further supports the concept that blood samples have fundamental importance for medical research. Tissue samples were also commonly used and occurred in 39.7% of the research sample collections, often combined with other types of samples. In total, 96.9% of the 131 sample collections included samples collected for healthcare, showing the importance of healthcare as a research infrastructure. Of the collections that had accessed existing samples from healthcare, as much as 96.3% included tissue samples from the Department of Pathology, which shows the importance of pathology samples as a resource for medical research. Analysis of different research areas shows that the most common of known public health diseases are covered. Collections that had generated the most publications, up to over 300, contained a large number of samples collected systematically and repeatedly over many years. More knowledge about existing biobank materials, together with public registries on sample collections, will support research collaborations, improve transparency, and bring us closer to the goals of biobanks, which is to save and prolong human lives and improve health and quality of life.
    Biopreservation and Biobanking 10/2014; 12(5):325-31.
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    ABSTRACT: Nottingham Health Science Biobank (NHSB) was established in 2011 by a 3-year "pump priming" grant from the United Kingdom National Institute of Health Research. Before biobanking operations began, NHSB commissioned a financial report on the full costs of biobanking and worked with key stakeholders and external consultants to develop a business plan with the aim of achieving financial and operational sustainability. The plan included: scanning published information, telephone interviews with commercial companies, Freedom of Information Requests, dialogue with prospective customers, and a market analysis of global trends in the use of human tissue samples in research. Our financial report provided a comprehensive and structured costing template for biobanking and confirmed the absolute requirement to ensure cost-efficient processes, careful staff utilization, and maximization of sample turnover. Together with our external consultants, we developed a business model responsive to global interest in healthcare founded on i) identification of key therapeutic areas that mapped to the strengths of the NHSB; ii) a systematic approach to identifying companies operating in these therapy areas; iii) engagement with noncommercial stakeholders to agree strategically aligned sample collection with the aim of ensuring the value of our tissue resource. By adopting this systematic approach to business modelling, the NHSB has achieved sustainability after less than 3 years of operation.
    Biopreservation and Biobanking 10/2014; 12(5):312-6.
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    ABSTRACT: Preservation of biospecimens for biobanking applications traditionally involves freezing while maintaining the integrity of the product throughout multiple freeze-thaw cycles. The protection and stabilization of DNA at room temperature (RT) may eliminate the costs associated with freezer storage and reduce the maintenance costs for biobanks. However, there is a paucity of information describing the yield, purity, and integrity of DNA extracted from biospecimens stored at RT. To evaluate the yield, purity, and integrity of DNA extracted from whole blood samples stored at RT (18°C), low (-20°C), and ultra-low (-80°C) temperatures, whole blood samples from sheep and human subjects were collected, and aliquots were stored at RT (18°C), -20°C, and -80°C. Blood samples at RT were stored utilizing biostabilization technology designed to protect genomic DNA in whole blood. The quantification of the extracted DNA was determined by spectrophotometry, and the integrity was assessed following gel electrophoresis. Storage temperature did not influence the DNA yield (p=0.52); DNA yield averaged 13.6±1.2 ng/μL across all storage temperatures. However, DNA yield was influenced (p=0.04) by species. The DNA yield was not influenced by a species×storage temperature interaction (p=0.84). Among the samples stored at RT, the species, type of technology utilized, and the interaction did not influence (p>0.13) DNA yield for both DNAgard and DNAstable. The 260/280 ratio was influenced by a species×storage temperature interaction (p=0.01). Generally, the 260/280 ratios were higher (p<0.05) for human samples stored at low and ultra-low temperatures compared to sheep samples stored at similar temperatures. Ambient temperature-based technologies offer an alternative to low temperature biospecimen preservation for blood that can be utilized by biobanks to reduce freezer storage costs while maintaining the quality of the biospecimen.
    Biopreservation and Biobanking 10/2014; 12(5):332-6.
  • Biopreservation and Biobanking 10/2014; 12(5):358-60.
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    ABSTRACT: Genetically modified animals are unique models with enormous scientific potential. Cryopreservation of pre-implantation embryos or of spermatozoa is a common approach to save those lines. The breeding of a line can be discontinued if a sufficient number of samples have been cryopreserved. To maintain the opportunity to recover a line, it is mandatory to assess the quality of the cryopreserved samples and to assure safe long-term storage conditions. Here, we investigated the revitalization rate of cryopreserved pre-implantation embryos stored in-house up to 158 months, of imported (and shipped) embryos, and of embryos received after in vitro fertilization. The storage period did not affect the revitalization rate, whereas the recovery of imported embryos was significantly reduced, possibly due to shipment conditions. The genotypes of genetically modified pups received following embryo-transfer were slightly smaller than expected by Mendelian laws. Intensive investigations of the hygienic state of the cryopreserved samples and the equipment used never showed microbiological contamination of a sample within a cryo-tube. However, environmental organisms were found frequently in the permanent freezers and dry shippers used. Since such contamination cannot be completely excluded and an embryo-transfer might not lead in all cases to a secure rederivation, foster mothers and revitalized pups should be housed in an intermediate facility and their health assessed before introducing them into the target facility.
    Biopreservation and Biobanking 10/2014; 12(5):343-50.
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    ABSTRACT: The aim of this study was to evaluate the efficiency of different media in the in vitro culture of bovine preantral follicles that were used either fresh or following slow freezing treatment. Frozen and fresh noncultured or cultured ovarian fragments were processed for histological, viability, and cell proliferation analyses. For cryopreservation, a solution containing 1.5 M ethylene glycol was frozen in a programmable biological freezer. After thawing, a portion of the samples was destined for frozen controls. The remainder were cultured in vitro for 5 days in three media: α-MEM, McCoy, or M199. Samples from these culture media were collected on days 1 and 5 for quantification of reactive oxygen species (ROS) and for hormonal assays. In fresh-cultured tissues, the percentage of morphologically normal follicles was significantly higher when cultured in M199 compared to that in the other media. In frozen-cultured tissues, McCoy medium was significantly superior to the other media, and was the only treatment that helped in maintaining the viability similar to fresh and frozen controls. Upon quantification of the nucleolus organizer region, we observed greater proliferation of granulosa cells in the frozen-cultured tissues with McCoy medium, and lesser proliferation in fresh-cultured tissues only with α-MEM. In frozen-cultured tissues, ROS levels were highest at day 1 and progressively reduced during culture, independent of the media used. In conclusion, under the conditions used in this study, the M199 and McCoy media are recommended for the culture of follicles derived from fresh and frozen ovarian tissues, respectively.
    Biopreservation and Biobanking 10/2014; 12(5):317-24.
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    ABSTRACT: Method validation is one of the crucial processes for a professional biobank. However, there are no routine guidelines specially designed for such studies. Therefore, in line with the need for competence in testing and calibration, the International Organization for Standardization (ISO) concept has been introduced to biobanking as a model for Quality Management Systems in this field. Accurate interpretation of the experimental data about the human genome depends on the quality of the genomic DNA. In this study, we focused on the validation of DNA quantitation by spectrophotometry, a basic bio-analytical method in molecular biology. The key factors of precision, accuracy testing, and linearity assessment are presented in assessing the method quality. Internal and external quality controls have been included as required. Our data show that the method of spectrophotometry is qualified for DNA quantitation.
    Biopreservation and Biobanking 08/2014;
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    ABSTRACT: Cryopreservation of mesenchymal stem cells (MSCs) is important because of their commercial applications in the clinical sector. MSCs are vulnerable to cryopreservation-induced apoptosis due to activation of apoptosis-related proteins during thawing. But the relationship between cryopreservation and apoptosis is not well understood. MSCs derived from umbilical cord blood were cryopreserved using Me2SO as the cryoprotective agent, with or without pre-treatment with the general caspase inhibitor z-VAD-FMK, or with the more selective caspase inhibitors z-IETD-FMK, z-LEHD-FMK and z-DEVD-FMK. To evaluate the effect of the calcium-mediated pathway, cryopreserved MSCs were tested with and without a calpain inhibitor. FACS was used to measure cell viability, mitochondrial membrane potential, and cell cycle analysis. Processing of the pro-caspases-3, -8, -9, calpain and Bid were determined by Western blotting. Cryopreservation of MSCs resulted in characteristic apoptosis within 24 h after thawing. Results show that intrinsic, extrinsic, and calpain pathways are activated after cryopreserved MSCs are thawed. Compared to selective caspase inhibitors, a general caspase inhibitor blocked DNA degradation more effectively and also inhibited caspases-3 and -8 processing as well as Bid cleavage, showing the beneficial effect of reducing cryopreservation-induced apoptosis. Similarly, calpain inhibition reduced cryopreservation-induced apoptosis. These data indicate that caspase-mediated extrinsic and intrinsic pathways and the proteolytic calpain cascade were activated after cryopreservation using a standard cryopreservation protocol. This activation might play an important role in the process of cryopreservation-induced cell death. Furthermore, the inhibition of calpain activity and caspase-mediated pathways might improve preservation efficacy.
    Biopreservation and Biobanking 08/2014; 12(4):246-254.
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    ABSTRACT: Protozoa have been widely used for the study of cryopreservation. The survival rate after cryopreservation has always received the most attention, while the cell viability during the process of freezing and thawing has been much less studied. In the present study, we report successful cryopreservation of Trypanosoma brucei, a parasitic protozoa of human and animals, using controlled-rate freezing at 5°C/min, and real-time observation of activity using a microscope differential scanning calorimeter system during the freezing and thawing process. Trehalose used as a cryoprotective agent at a concentration of 0.4 M allowed the trypanosomes to endure freezing and thawing with >89% survival rate. Results from mechanisms analysis indicate that vitrification by trehalose contributes significantly to the protection of the trypanosomes from damage at low temperature.
    Biopreservation and Biobanking 08/2014; 12(4):265-268.
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    ABSTRACT: Over the past two decades, researchers have increasingly used human biospecimens to evaluate hypotheses related to disease risk, outcomes and treatment. We conducted an analysis of population-science cancer research grants funded by the National Cancer Institute (NCI) to gain a more comprehensive understanding of biospecimens and common derivatives involved in those studies and identify opportunities for advancing the field. Data available for 1,018 extramural, peer-reviewed grants (active as of July 2012) supported by the Division of Cancer Control and Population Sciences (DCCPS), the NCI Division that supports cancer control and population-science extramural research grants, were analyzed. 455 of the grants were determined to involve biospecimens or derivatives. The most common specimen types included were whole blood (51% of grants), serum or plasma (40%), tissue (39%), and the biospecimen derivative, DNA (66%). While use of biospecimens in molecular epidemiology has become common, biospecimens for behavioral and social research is emerging, as observed in our analysis. Additionally, we found the majority of grants were using already existing biospecimens (63%). Grants that involved use of existing biospecimens resulted in lower costs (studies that used existing serum/plasma biospecimens were 4.2 times less expensive) and more publications per year (1.4 times) than grants collecting new biospecimens. This analysis serves as a first step at understanding the types of biospecimen collections supported by NCI DCCPS. There is room to encourage increased use of archived biospecimens and new collections of rarer specimen and cancer types, as well as for behavioral and social research. To facilitate these efforts, we are working to better catalogue our funded resources and make that data available to the extramural community.
    Biopreservation and Biobanking 08/2014; 12(4):240-245.
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    ABSTRACT: The question of how best to attribute the unit costs of the annotated biospecimen product that is provided to a research user is a common issue for many biobanks. Some of the factors influencing user fees are capital and operating costs, internal and external demand and market competition, and moral standards that dictate that fees must have an ethical basis. It is therefore important to establish a transparent and accurate costing tool that can be utilized by biobanks and aid them in establishing biospecimen user fees. To address this issue, we built a biospecimen user fee calculator tool, accessible online at . The tool was built to allow input of: i) annual operating and capital costs; ii) costs categorized by the major core biobanking operations; iii) specimen products requested by a biobank user; and iv) services provided by the biobank beyond core operations (e.g., histology, tissue micro-array); as well as v) several user defined variables to allow the calculator to be adapted to different biobank operational designs. To establish default values for variables within the calculator, we first surveyed the members of the Canadian Tumour Repository Network (CTRNet) management committee. We then enrolled four different participants from CTRNet biobanks to test the hypothesis that the calculator tool could change approaches to user fees. Participants were first asked to estimate user fee pricing for three hypothetical user scenarios based on their biobanking experience (estimated pricing) and then to calculate fees for the same scenarios using the calculator tool (calculated pricing). Results demonstrated significant variation in estimated pricing that was reduced by calculated pricing, and that higher user fees are consistently derived when using the calculator. We conclude that adoption of this online calculator for user fee determination is an important first step towards harmonization and realistic user fees.
    Biopreservation and Biobanking 08/2014; 12(4):234-239.
  • Biopreservation and Biobanking 08/2014; 12(4):223-224.
  • Biopreservation and Biobanking 08/2014; 12(4):284-285.