Zentrales Biobanking am Beispiel der Medizinischen

Hochschule Hannover (MHH)

Hannover Unified Biobank

Prof. Dr. Thomas Illig

CEO and Scientific Head of Hannover Unified Biobank (HUB)

23. 06. 2015, University of Innsbruck

What is a biobank?

• Term "biobank" first appeared in the scientific literature in 1996

• Biological collections of human, animal, plant or microbial samples

• Sample collections with associated sample data

• Collections that are managed according to professional standards

�Growing impact on medical research

� Huge public health opportunity

Potential of biobanks

• Huge potential (markers, drugs,• individualized medicine, patho-

etiology)

• New technologies mapping themolecules of life (genes, transcripts, proteins, metabolites)

• Controversial

• Money (cost)

• Real value already coming

Biobanking is one of them

Importance of biobanks

Cancer Genome Atlas (CGA)

• Aim: systematic exploration of the entire spectrum of genomic changes involved in human cancer

• “You might have thought that doing the science would be the biggest challenge of a massive undertaking like the Cancer Genome Atlas,”

• “But acquiring the biospecimens turned out to be the hardest 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 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)

• …

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 BMBF funding eg Jena, Leipzig, Dresden, Hannover, Mannheim, Gießen, Essen, …

• Many other German universities plan centralized biobanks

Central professional biobank at Hannover Medical School (MHH)Hannover Unified Biobank = HUB

Central professional biobank at Hannover Medical School (MHH)Hannover Unified Biobank = HUB

• Establishment of a professional, modern, unified and

harmonized biobank at MHH

Important quality features for professional biobanking

1. Sample quality (processes, infrastructure, capacity)

2. IT-Data quality and security (Biobank information system, pseudonymisation)

3. Governance, access and owner rights

4. Project management

5. Certification of biobank processes

6. Education and training

Often 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 in

Hannover• 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 Research Center Hannover (CRC), June 2014

Important quality features for modern biobanking

1. 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 data

4. Project management

5. Certification of biobank processes

6. Education and training

Often 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 under-

ground line

• 200 m2 of lab space

− automated sample preparation for body liquids

− automated DNA and RNA extraction

1. Processes and workflow lab; body liquids

• 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 HUB

Storage capacity: 6 million 1 ml tubes

1. Automated Storage

Important quality features for modern biobanking

1. 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 data

4. Project management

5. Certification of biobank processes

6. Education and training

Often only possible in large centralbiobanks

2. IT-Data quality and security

Biobank 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 HUB

Biobank-Information System

(BIMS)

Liquid nitrogen-

tanks

diagnoses,

basic data

clinical data,

molecular data

Analysis / Research

sample- /

analysis data

temperature,

liquid Level, sample

content

Lab system MHH(opus::L)

sample quality data

Scanner

rack-ID, sample-ID,

sample-position, working step

Hamilton ----80°C robot

jobs, positions, IDs

Pseudonymization(ZIMt)

Master Patient Index (MPI) / (Mainzelliste)

Biobank-

Pseudonym

(PID1)

cinical data DNA/RNAextraction

robot

Liquid-Handling-

Robot

Clinical systemsMHH (SAP, Sub-

Systems)

Study- / researchsystems

Datawarehouse(MHH/ZIMt)

analysis-pseudonym (PID2)

identifying data (IDAT)

study data,

consent-status,

external pseudonym

(PIDe)

position, IDs

pick lists / jobs

Important quality features for modern biobanking

1. 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 data

4. Project management

5. Certification of biobank processes

6. Education and training

Often only possible in large centralbiobanks

3. Governance, access and owner rights

Important quality features for modern biobanking

1. 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 data

4. Project management

5. Certification of biobank processes

6. Education and training

Often 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, Deutsches Biobankregister, 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 modern biobanking

1. 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 data

4. Project management

5. Certification of biobank processes

6. Education and training

Often 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 modern biobanking

1. 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 data

4. Project management

5. Certification of biobank processes

6. Education and training

Often only possible in large centralbiobanks

6. Education and training

• Biobanking day (4 x per year)

• User training IT/BIMS: my samples/Centraxx (up to 6 times per year)

• Different biobank lectures at MHH

• Guided tours in biobank

HUB Team

Norman Klopp, Markus KerstingInga Bernemann, Jana Prokein

Dirk Drobek, Karin HeineSisko Bauer, Mercedes Clavero

Bettina Wilhelm, Manfred MertinThomas Illig

Not presented: Christina Hartmann, Urbana Perez-Martin, Kordula Brückmann

Thank you very much for your attention

• Asthma: KIRA , PASTURE, SOLAR, GABRIEL, ISAAK, PARSIFAL, PARSIFAL TUSCON, 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

DZL samples and projects in HUB

[Coriell Institute, New Jersey]

Sample quality in HUB

• Excellent storage conditions for millions of samples

• High grade of automation in storage and pre-analytics (Hamilton Systems)

• Emergency power supply and alarm system

• Continuous temperature monitoring

• Barcodes for sample identification

• Sample tracking during all steps of pre analytics, storage and retrieval