Developments in biobanking workflow standardization providing sample integrity and stability.

Recommendations and outlines for standardization in biobanking processes are presented by a research team with long-term experience in clinical studies. These processes have important bearing on the use of samples in developing assays. These measurements are useful to document states of health and disease that are beneficial for academic research, commercial healthcare, drug development industry and government regulating agencies. There is a need for increasing awareness within proteomic and genomic communities regarding the basic concepts of collecting, storing and utilizing clinical samples. Quality control and sample suitability for analysis need to be documented and validated to ensure data integrity and establish contexts for interpretation of results. Standardized methods in proteomics and genomics are required to be practiced throughout the community allowing datasets to be comparable and shared for analysis. For example, sample processing of thousands of clinical samples, performed in 384 high-density sample tube systems in a fully automated workflow, preserves sample content and is presented showing validation criteria. Large studies will be accompanied by biological and molecular information with corresponding clinical records from patients and healthy donors. These developments position biobanks of human patient samples as an increasingly recognized major asset in disease research, future drug development and within patient care. BIOLOGICAL SIGNIFICANCE: The current manuscript is of major relevance to the proteomic and genomic fields, as it outlines the standardization aspects of biobanking and the requirements that are needed to run future clinical studies that will benefit the patients where OMICS science will play a major role. A global view of the field is given where best practice and conventional acceptances are presented along with ongoing large-scale biobanking projects. The authors represent broadly stakeholders that cover the academic, pharma, biotech and healthcare fields with extensive experience and deliveries. This contribution will be a milestone paper to the proteomic and genomic scientists to present data in the future that will have impact to the life science area. This article is part of a Special Issue entitled: Standardization and Quality Control in Proteomics.

Blood plasma reference material: a global resource for proteomic research.

There is an ever-increasing awareness and interest within the clinical research field, creating a large demand for blood fraction samples as well as other clinical samples. The translational research area is another field that is demanding for blood samples, used widely in proteomics, genomics, as well as metabolomics. Blood samples are globally the most common biological samples that are used in a broad variety of applications in life science. We hereby introduce a new reference blood plasma standard (heparin) that is aimed as a global resource for the proteomics community. We have developed these reference plasma standards by defining the Control group as those with C-reactive protein levels <3 mg/L and a Disease group with C-reactive protein ranges >30 mg/L. In these references we have used both newborn children 1-2 weeks, as well as youngsters 15-30 years, and middle aged 30-50 years, and elderly patients at the ages of 65+. In total, there were 80 patients in each group in the reference plasma pools. We provide data on the developments and characteristics of the reference blood plasma standards, as well as what is used by the team members at the respective laboratories. The standards have been evaluated by pilot sample processing in biobanking operations and are currently a resource that allows the Proteomic society to perform quantitative proteomic studies. By the use of high quality reference plasma samples, global initiatives, such as the Chromosome Human Proteome Project (C-HPP), will benefit as one scientific program when the entire human proteome is mapped and linked to human diseases. The plasma reference standards are a global resource and can be accessed upon request.

Standardization developments for large scale biobanks in smoking related diseases - a model system for blood sample processing and storage.

BACKGROUND: Biobank samples stored in biobanks give researchers and respiratory healthcare institutions access to datasets of analytes valuable for both diagnostic and research practices. The usefulness of these samples in clinical decision-making is highly dependent on their quality and integrity. New procedures that better preserve sample integrity and reduce degradation are being developed to meet the needs of both present and future biobanking. Hereby we present an automatic sample workflow scheme that is designed to handle high numbers of blood samples. METHODS: Blood fractions are aliquoted, heat sealed using novel technology, and stored in 384 tube high-density sample arrays. RESULTS: The newly developed 384 biobank rack system is especially suited for preserving identical small aliquots. We provide data on robotic processing of clinical samples at -80°C, following initial processing, analysis and shipping between laboratories throughout Europe. Subsequent to unpacking, re-sorting, and storage at these sites, the samples have been returned for analysis. Biomarker analysis of 13 common tests in the clinical chemistry unit of the hospital provides evidence of qualitative and stable logistics using the 384-sample tube system. CONCLUSIONS: This technology development allows rapid access to a given sample in the frozen archive while maintaining individual sample integrity with sample tube confinement and quality management.

Large scale biobanking of blood - the importance of high density sample processing procedures.

OBJECTIVE: The aim of this study is a novel automated sample-processing concept for future proteomics and clinical research, performing patient studies from resulting blood fractions in various disease areas. Another aim is biobank storage of small sample volumes, where each sample aliquot can be used for a dedicated clinical analysis and end-point measurement in order to preserve sample integrity and value over time. METHODS: 96 and 384 format sample storage tube systems were utilized for preservation and archiving of clinical patient samples. Automated sample processing and aliquoting were achieved using robotic liquid handling instrumentation, followed by biomarker assay quantitations. Sample workflow was documented and tracked by Nautilus LIMS. RESULTS: Validation by repetitive processing and analysis confirmed the reliability of automated high density 384 format aliquoting. This high density scaling allows for reproducible aliquoting of 70-µL volumes of blood. Plasma with EDTA, Li-heparin, and citrate, as anti-coagulants, fractioned along with the buffy coat (leukocytes) and the erythrocyte fraction. Large scale processing of 11,000 sample aliquots resulted in a 99.8% process fulfillment. CONCLUSION: Our results demonstrate that robust results can be generated from an automated sample processing strategy, isolating plasma, buffy coat, erythrocytes, serum and whole blood, proven by quantitation of 23 common markers used in everyday healthcare around the world. This article is part of a Special Issue entitled: Integrated omics.