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Zentrales Biobanking am Beispiel der MedizinischenHochschule Hannover (MHH)Hannover Unified BiobankProf. Dr. Thomas IlligCEO and Scientific Head of Hannover UnifiedBiobank (HUB)23. 06. 2015, University of Innsbruck

What is a biobank? Term "biobank" first appeared in the scientific literature in1996 Biological collections of human, animal, plant or microbialsamples Sample collections with associated sample data Collections that are managed according to professionalstandards

Potential of biobanks Huge potential (markers, drugs, individualized medicine, pathoetiology) New technologies mappingthemolecules of life (genes,transcripts, proteins, metabolites) Controversial Money (cost) Real value already comingBiobanking is one of themGrowing impact on medicalresearchHuge public health opportunity

Importance of biobanksCancer Genome Atlas (CGA) Aim: systematic exploration of the entire spectrum of genomicchanges involved in human cancer “You might have thought that doing the science would be thebiggest challenge of a massive undertaking like the CancerGenome Atlas,” “But acquiring the biospecimens turned out to be thehardest part, bar none. It’s the Wild West out there.”Carolyn ComptonNCI bio-repository chiefHead of Biomaterials Group for the CGA

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

Quality of analyzed data stronglydependent on quality of biomaterial

Centralized biomaterial banks cBMBs(BMBF funded: 25 million / 5 years) Aachen, Berlin, Heidelberg, Kiel,Würzburg, Munich (M4) Centralized biobanks without BMBFfunding eg Jena, Leipzig, Dresden,Hannover, Mannheim, Gießen, Essen, Many other German universities plancentralized biobanks

Central professional biobank atHannover Medical School (MHH)Hannover Unified Biobank HUB Establishment of a professional, modern, unified andharmonized biobank at MHH

Important quality features forprofessional biobanking1. Sample quality (processes, infrastructure, capacity)2. IT-Data quality and security (Biobank information system,pseudonymisation)3. Governance, access and owner rights4. Project management5. Certification of biobank processes6. Education and trainingOften only possible in large centralbiobanks

Medical School (MHH) Hannover More than 9000 employees Pure medical university (only one in Germany) Close collaboration with other 2 universities inHannover Fraunhofer ITEM, Helmholtz Braunschweig Participation in 2 German Health Centers (DZL,DZIF) 2 Excellence clusters (Rebirth, Hearing4all) 3 SFBs 8 Forschergruppen 5 „Kompetenznetzwerke“ 1 „IFB“ for transplantation 70 different clinics and institutes

Move to new building: Clinical ResearchCenter Hannover (CRC), June 2014

Important quality features for modernbiobanking1. Sample quality (processes, infrastructure, capacity)2. IT-data quality and security (Biobank informationmanagement system, pseudonymisation)3. Governance of biobank, access and owner rights of samplesand data4. Project management5. Certification of biobank processes6. Education and trainingOften only possible in large centralbiobanks

1. Sample quality (pre-analytics, storage,retrieval) HUB infrastructure in Clinical Research Center (CRC). 400 m2 of storage space for millions of samples automated -80 C repository (in construction) liquid nitrogen tanks and -80 C freezers(partly ordered) Connection to MHH via pneumatic underground line 200 m2 of lab space automated sample preparation for body liquids automated DNA and RNA extraction

1. Processes and workflow lab; bodyliquids All steps documented (Time stamps, temperature logging) Samples latest after 2 hours in freezer or N2 tank

1. Gapless documentation of biobankprocesses Pre-analytics and transport (time stamps) Storage and retrieval (constant temperature monitoring)

1. Pre-Analytics

1. Storage overview of HUBStorage capacity: 6 million 1 ml tubes

1. Automated Storage

Important quality features for modernbiobanking1. Sample quality (processes, infrastructure, capacity)2. IT-data quality and security (Biobank informationmanagement system, pseudonymisation)3. Governance of biobank, access and owner rights of samplesand data4. Project management5. Certification of biobank processes6. Education and trainingOften only possible in large centralbiobanks

2. IT-Data quality and securityBiobank Information Management System (BIMS) Currently MHH Enterprise MySamples Licence (MyData)200 users Customizing and development of MySamples (Scanner, searchfunction improved, protocols, reports, quality attributes, deliveryof samples to other institutes, ) New BIMS: Kairos CentraXX (used already in 15 other bigbiobanks in Germany) Customizing of CentraXX to MHH needs until Dec. 2016

2. Biobank Information System (BIMS) of HUBidentifying data (IDAT)Lab system MHH(opus::L)Clinical systemsMHH (SAP, SubSystems)Study- / researchsystemsPseudonymization(ZIMt)Master Patient Index(MPI) / (Mainzelliste)study data,consent-status,external pseudonym(PIDe)sample- /analysis datajobs, positions, IDscinical otdiagnoses,basic dataDatawarehouse(MHH/ZIMt)clinical data,molecular datarack-ID, sample-ID,sample-position, working stepBiobankInformation System(BIMS)sample quality dataAnalysis /Researchanalysis-pseudonym (PID2)position, IDspick lists / jobsHamilton ---80 C robotBiobankPseudonym(PID1)temperature,liquid Level, samplecontentLiquidnitrogentanks

Important quality features for modernbiobanking1. Sample quality (processes, infrastructure, capacity)2. IT-data quality and security (Biobank informationmanagement system, pseudonymisation)3. Governance of biobank, access and owner rights ofsamples and data4. Project management5. Certification of biobank processes6. Education and trainingOften only possible in large centralbiobanks

3. Governance, access and owner rights

Important quality features for modernbiobanking1. Sample quality (processes, infrastructure, capacity)2. IT-data quality and security (Biobank informationmanagement system, pseudonymisation)3. Governance of biobank, access and owner rights of samplesand data4. Project management5. Certification of biobank processes6. Education and trainingOften only possible in large centralbiobanks

4. Project management Biomaterials and volumes (serum, plasma, DNA, tissue,urine, ) SOPs (pre-analytics, transport, storage) Informed consent (Broad, project specific) IT management (sample registrationtool, MySamples, CentraXX) Publication of sample collections(BBMRI catalogue, DeutschesBiobankregister, MHH HUB website) Import of „old“ sample data toMySamples or CentraXX, transportof „old“ samples to HUB

4. Projects 500 000 samples in database 280 000 samples physically stored from altogether 130 projects

4. Third party funded projects German Centre for Lung Research (DZL) German Center for Infection Research (DZIF), Transplant cohort Integrated research and treatment center transplantation (IFBTx),BMBF Combatting bacterial resistance in Europe (EU IMI) Probase (Prostate cancer, Krebshilfe) DIGIT HF (Herzstiftung) German national cohort (local samples, Hannover / Braunschweig) Re-birth (Excellence initiative) NeoCyst (Polycystic kidneys, BMBF)

Important quality features for modernbiobanking1. Sample quality (processes, infrastructure, capacity)2. IT-data quality and security (Biobank informationmanagement system, pseudonymisation)3. Governance of biobank, access and owner rights of samplesand data4. Project management5. Certification of biobank processes6. Education and trainingOften only possible in large centralbiobanks

5. Certification of HUB DIN ISO 9001 certification in 2015 GAMP 5 validation of the IT system 2016 GxP conformity in 2018

Important quality features for modernbiobanking1. Sample quality (processes, infrastructure, capacity)2. IT-data quality and security (Biobank informationmanagement system, pseudonymisation)3. Governance of biobank, access and owner rights of samplesand data4. Project management5. Certification of biobank processes6. Education and trainingOften only possible in large centralbiobanks

6. Education and training Biobanking day (4 x per year) User training IT/BIMS: mysamples/Centraxx (up to 6 times peryear) Different biobank lectures at MHH Guided tours in biobank

Thank you very much for your attentionHUB TeamNorman Klopp, Markus KerstingInga Bernemann, Jana ProkeinDirk Drobek, Karin HeineSisko Bauer, Mercedes ClaveroBettina Wilhelm, Manfred MertinThomas IlligNot presented: Christina Hartmann, UrbanaPerez-Martin, Kordula Brückmann

DZL samples and projects in HUB Asthma: KIRA , PASTURE, SOLAR, GABRIEL, ISAAK, PARSIFAL, PARSIFALTUSCON, VERMEE, MAGICS, DNA, serum (Hansen) COPD: ABACOPD, different biomaterials (Welte, Barten) Cystic fibrosis: human and bacterial collections (Tümmler) ELD: body liquids from lung transplanted persons (Gottlieb) ELD: cells (Martin) PH: serum, plasma (Hoeper) Pneumonia and ALI: CAPNETZ, different biomaterials (Welte, Barten) Total of 120 000 DZL samples stored in HUB Extraction of 2 700 genomic DNA samples from CapNetz

Sample quality in HUB Excellent storage conditions for millions ofsamples High grade of automation in storage and preanalytics (Hamilton Systems) Emergency power supply and alarm system Continuous temperature monitoring Barcodes for sample identification Sample tracking during all steps of preanalytics, storage and retrieval[Coriell Institute, New Jersey]

Education andtraining Oftenonlypossiblein large central biobanks. . Center Hannover (CRC), June 2014. Important quality features for modern biobanking 1. Sample quality (processes, infrastructure, capacity) 2. IT-dataqualityandsecurity(Biobank information . COPD: ABACOPD, different biomaterials (Welte, Barten)