MHH-Biobank (Hannover Unified Biobank = HUB)

Transcription

1 MHH-Biobank (Hannover Unified Biobank = HUB) Prof. Dr. Thomas Illig CEO and scientific head of HUB Working since in Hannover MHH Klausurtagung, Bad Pyrmont,

2 Personal Biobanking Experience Director of Research Unit of Molecular Epidemiology at Helmholtz Zentrum München Head of KORA Biobank Population-based study including adults from Munich Head of Biobank of German National Cohort participants, 18 study centers (Hanover/Brunswick) Workpackage leader in Munich Biobank Alliance on personalized medicine (M 4 excellence initiative) Work package leader in different EU-funded biobanking projects (BIOSHARE, BBMRI)

3 What is a biobank? Collection of biomaterials and data

4 Biobanks work hard to keep things cold!

5 But biobanks are cooking

6 Why is biobanking so hot? Huge potential (markers, drugs, individualized medicine, pathoetiology) New technologies mapping the molecules of life (genes, transcripts, proteins, metabolites) Controversial Money (cost) Real value already coming Biobanking is one of them Growing impact on medical research Huge public health opportunity

7 What may be problems of small biobanks No second temperature control and no alarm system available No personnel to take care for freezer problems on bank holidays, weekends or during the night (samples are damaged) No emergency power available No empty back-up freezer available Icing No data banks that safe storage or quality data of samples No data security (Pseudonymization)

8 GIGO = Garbage in garbage out

9 Why is centralized biobanking important High sample quality and standardization of samples is important for the development of new innovative diagnostics! National and international research networks are getting more important Samples from different sources have to be combined Molecular techniques are getting more sensitive Sample quality more and more important Sample security is mandatory Biobanking infrastructure is complex Data security is mandatory Grant applications get easier granted

10 Similar biobanking iniatives in Germany Centralized biomaterial banks = cbmbs (BMBF funded) Aachen, Berlin, Heidelberg, Kiel, Würzburg, Munich (M 4 ) Centralized biobanks without BMBF funding eg Jena, Leipzig, Dresden, Hannover Many other universities plan centralized biobanks MHH still one of the pioneers

11 HUB, Major aims Establishment of a professional, modern, unified and harmonized biobank at CRC Clinical or study partners stay owner of samples

12 Status quo Interim solution: Pediatric Research Center (PFZ, storage in liquid nitrogen tanks and -80C freezers with monitoring and alarm systems) Update of existing sample collections at MHH and integration of new MHH partners into HUB Advancement of biobanking software and data bank (my samples) and development of sample tracking via 2D barcode tubes and barcode readers Planning of biobank in CRC including facility, instruments, pneumatic underground line,

13 Location of HUB in 2013 Planned move of biobank to Clinical Research Center (CRC) building in 2013 Connection to pneumatic underground line of MHH 500 m 2 of storage space (automated -80 C repository, liquid nitrogen and -80C freezer working archives) 200 m 2 of lab space (automated sample preparation for body liquids, automated DNA and RNA extraction, cell culture access, )

14 Infrastructure, harmonisation tools of HUB in CRC Strict SOPs and highest sample quality High grade of automation in pre-analytics, storage and retrieval Strict sample tracking during all steps of pre-analytics, storage and retrieval of samples LIMS (Laboratory Information Management System) and BIMS (Biobank Information Management System) Sample identification by 2D barcodes Storage in liquid nitrogen and automated -80 repository Continuous temperature monitoring Oxygen control Continuous sample observation Emergency power supply Elaboration of patient consent forms with ethic specialists and lawyers Development of data safety concepts

15 HUB: Included samples Inclusion of all sample collections of MHH in biobanking data bank (my samples) and storage of samples centrally where this makes sense Inclusion of part of biomaterials of Fraunhofer and National Cohort Hanover/Brunswick (n=10 000)

16 German National Cohort (GNC) adult participants Population based 18 study centers Head of biomaterials group Local storage of 1/3 of samples Local samples of Brunswick / Hanover will be processed and stored by HUB

17 Biomaterials Blood and blood derivates (serum, plasma, erythrocytes, leukocytes, Urine Tissues (liver, kidney, lung, ) Cells Lung lavage (BAL) Swabs (nasal, pharyngal, skin, ) Micro-organisms

18 Sample related data storage (My samples) Sample localisation software 2D barcode tracking Improvement to functional Biobank information system (BIMS) necessary

19 My samples data bank organisation Org. n Org. 2 User Java Clients HUB sample data bank Biobank High data security provided by ZIMT

20 Sample localisation tool Building Freezer Room sample AL1076 Rack Box

21 MySamples database: 2D barcode scanning tool 11 departments at MHH already work with single 2D-barcode scanners

22 Available biomaterials at MHH (2010) and number of samples in HUB my samples (2012) 1.81 million samples at MHH in 2010) AG Bioproben, 2010 HUB MySamples: (from 27 institutes) IFBTx, DZL, DZIF, Re-birth, National Cohort, 11 further third party applications with participation of HUB submitted

23 Ethics, data security and certification Harmonized ethics and informed consent procedures together with lawyers and ethics specialists from Hannover (Cells, MHH and Leibnitz University) Broad consent planned for Germany Establishment of data security concept (in co-operation with TMF and Prof. Kuhn Munich) Certification of Biobank

24 Storage conditions and extraction at CRC Automated repository: Hamilton, Liconic, Nexus, Matrical Manual storage: Storage of most liquid samples in liquid nitrogen tanks For retrieval: transfer of samples to Automated repository High quality Fully automated DNA/RNA extraction System from Hamilton (bead based, high DNA quality)

25 Thank you very much for your attention!!

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27 direct access votes appoints Planned governance of Hannover Unified Biobank supervisory board advices external scientific advisory board suggests steering board confirms HUB team general assembly of owner access commitees prioritizes permits/consents owner

28 Future IT-Solution Clinical data Clinical data, PID Pseudonymisation Meta data, pseudonymisation MPI (pseudonym) Datawarehouse BIMS Analysis result Sample data, sample quality Process and quality tracking Data analysis Meta data quality of sample analysis Storage

29 Sample and information flow OPs Clinic s ITE M EPI studie s Clinical data storage Centres tissues, cells, bioorganisms Central service tissues Repository tissues Central service Body liquids, DNA, RNA, swabs, Central repository backup Central Biobank at CRC body liquids, swabs.. Central service Living cells Repository bioorganisms Sample data storage (mysample s) Automated high quality retrieval of samples Analysis data storage Analysis of samples

30 Sample processing at HUB in CRC Sample collection at clinics (body fluids) Sample transport to CRC (undergro und delivery from every clinic ) Automated preanalytics where possible Automated storage and retrieval Biobank information system (BIMS), sample tracking Storage in CRC Back-up with clinics Automated sample retrieval for partner Separated repositories for tissues and bioorganisms

31 HUB, major concepts unified harmonized biobank Central biorepository Partners stay owner of samples Exchange of materials Clinics OPs EPI studies ITEM

32 Sample processing at HUB in CRC Sample collection at clinics (body fluids) Sample transport to CRC (undergroun d delivery from every clinic ) Automated pre-analytics where possible Automated storage and retrieval Biobank information system (BIMS), sample tracking (Dr. Varsani) Storage in CRC Back-up with clinics Automated sample retrieval for partner Separated repositories for tissues and bioorganisms

33 Biomaterials Blood and blood derivates (serum, plasma, erythrocytes, leukocytes, Urine Tissues (liver, kidney, lung, ) Cells Lung lavage (BAL) Swabs (nasal, pharyngal, skin, )

34 votes appoints direct access Planned governance of Hannover Unified Biobank supervisory board advices external scientific advisory board suggests steering board confirms HUB team access commitees prioritizes general assembly of owner permits/consents owner