title: Developments in biobanking workflow standardization providing sample integrity and stability.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Dept. of Laboratory Medicine, Section for Clinical Chemistry, Lund University, Skåne University Hospital in Malmö, SE-205 02 Malmö, Sweden.
authors.forename: Johan
authors.initials: J
authors.lastname: Malm
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Fehniger
authors.forename: Pia
authors.initials: P
authors.lastname: Danmyr
authors.forename: Akos
authors.initials: A
authors.lastname: Végvári
authors.forename: Charlotte
authors.initials: C
authors.lastname: Welinder
authors.forename: Henrik
authors.initials: H
authors.lastname: Lindberg
authors.forename: Roger
authors.initials: R
authors.lastname: Appelqvist
authors.forename: Karin
authors.initials: K
authors.lastname: Sjödin
authors.forename: Elisabet
authors.initials: E
authors.lastname: Wieslander
authors.forename: Thomas
authors.initials: T
authors.lastname: Laurell
authors.forename: Sophia
authors.initials: S
authors.lastname: Hober
authors.forename: Frode S
authors.initials: FS
authors.lastname: Berven
authors.forename: David
authors.initials: D
authors.lastname: Fenyö
authors.forename: Xiangdong
authors.initials: X
authors.lastname: Wang
authors.forename: Per E
authors.initials: PE
authors.lastname: Andrén
authors.forename: Goutham
authors.initials: G
authors.lastname: Edula
authors.forename: Elisabet
authors.initials: E
authors.lastname: Carlsohn
authors.forename: Manuel
authors.initials: M
authors.lastname: Fuentes
authors.forename: Carol L
authors.initials: CL
authors.lastname: Nilsson
authors.forename: Magnus
authors.initials: M
authors.lastname: Dahlbäck
authors.forename: Melinda
authors.initials: M
authors.lastname: Rezeli
authors.forename: David
authors.initials: D
authors.lastname: Erlinge
authors.forename: György
authors.initials: G
authors.lastname: Marko-Varga
mesh_terms: D057205:Automation, Laboratory / Q000379:methods / Q000592:standards; D018070:Biological Specimen Banks / Q000592:standards*; D006801:Humans; D040901:Proteomics / Q000379:methods / Q000592:standards; D013048:Specimen Handling / Q000379:methods / Q000592:standards
keywords: Antibodies; Biobank; Diseases; Mass spectrometry; Proteins; Standardization