Developments in Biobanking Workflow Standardization Providing Samples Integrity and Stability

Recommendations and outlines for standardization in biobanking processes are presented by a research team with long-term experiences 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 proteomics and genomics communities regarding the basic concepts of collecting, storing and utilizing clinical samples. Quality control and samples suitability for analysis needs 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, is presented showing validation criteria. Large studies will be accompanied by biological, 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