Blueprint for building a biorepository in a resource-limited setting that follows international best practices

Abstract

Background: Genetic diversity is abundant on the African continent. However, genomic research has been hampered by a lack of high quality and extensively annotated biospecimens and the necessary infrastructure to support such a technology-intensive effort.

Objective: The Institute of Human Virology Nigeria (IHVN) partnered with the H3Africa Consortium and the Coriell Institute for Medical Research to build an internationally recognised biorepository for the receipt, processing, storage and distribution of biospecimens for biomedical research. Here, the authors describe the procedures, challenges and results encountered.

Results: Key requirements for a high-quality biorepository were identified: (1) institutional support of infrastructure and services, (2) on-site trained staff with primary commitment to the biorepository, (3) reliance on best practices from globally recognised biorepository groups, (4) early implementation of a quality management system, (5) adoption of a laboratory information management system with demonstrated versatility in functions, (6) collaboration with external experts and sharing of experience through abstracts, newsletters, published manuscripts, and attendance at meetings and workshops, (7) strict adherence to local and national ethical standards and (8) a sustainability plan that is reviewed and updated annually.

Conclusion: Utilising published best practices of globally recognised experts in the biorepository field as a benchmark, IHVN expanded and reorganised its existing laboratory facility and staff to take on this new purpose.

Keywords: best practices; biobank; biorepository; developing country; international guidelines.

FIGURE 1

Flowchart of the process to bring IHVN H3Africa biorepository to international biorepository standards. Activities undertaken by the Institute of Human Virology Nigeria-H3Africa Biorepository to achieve compliance with Biorepository ‘Best Practices’ are shown in coloured boxes: dark aqua are initial activities and final outcomes; pink are activities undertaken by IHVN H3Africa biorepository staff; medium blue are activities carried out by the independent consultant; yellow are major policy determinations.

FIGURE 2

Audit topics and results provided by IHVN H3Africa biorepository consultant. This graph presents a quantitative assessment of IHVN H3Africa biorepository performance on each external audit by the independent consultant. Horizontal axis: proportion of the maximum possible score. Vertical axis: major operational areas examined during each audit.

FIGURE 3

IHVN H3Africa Biorepository organisational chart and staff responsibilities. The IHVN staff positions shared with IHVN H3Africa biorepository are indicated by the purple outline; solely IHVN H3Africa biorepository staff by the aqua outline; University of Maryland, Baltimore by the red outline; dual IHVN/UMB by the double red outline; technical advisor and consultant by white boxes.

FIGURE 4

Expansion of IHVN H3Africa biorepository infrastructure to support an international biorepository. The initial 1309 ft² biorepository space is shown in the black outline of the left of the figure. This space was reconfigured and a 768 ft² cryogenic room was added (green outline). A second expansion (red outline) added 773 ft² of secure biorepository storage space.

FIGURE 5

Security installations at Institute of Human Virology Nigeria H3Africa biorepository. (a) Biometric access control panel. (b) Motion-activated closed circuit television camera. (c) Monitor display from closed circuit television camera showing both interior and exterior areas of biorepository.

FIGURE 6

Remote temperature monitoring. Features of the SmartVue Temperature System are shown. (a) Digital temperature display available on individual ultra-low temperature freezers. (b) Continuous temperature readout for each freezer accessible on Web. (c) An email alert is sent whenever the temperature of an individual freezer exceeds limits set by biorepository management.