Hannover Unified Biobank

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
Potential of biobanks
• Huge potential (markers, drugs,
• individualized medicine, pathoetiology)
• New technologies mapping
themolecules 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
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 Compton
NCI bio-repository chief
Head 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 strongly
dependent 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
• 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 central
biobanks
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 information
management system, pseudonymisation)
3. Governance of biobank, access and owner rights of samples
and data
4. Project management
5. Certification of biobank processes
6. Education and training
Often only possible in large central
biobanks
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; body
liquids
•
All steps documented (Time stamps, temperature logging)
•
Samples latest after 2 hours in freezer or N2 tank
1. Gapless documentation of biobank
processes
•
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 information
management system, pseudonymisation)
3. Governance of biobank, access and owner rights of samples
and data
4. Project management
5. Certification of biobank processes
6. Education and training
Often only possible in large central
biobanks
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, search
function improved, protocols, reports, quality attributes, delivery
of samples to other institutes, …)
•
New BIMS: Kairos CentraXX (used already in 15 other big
biobanks in Germany)
•
Customizing of CentraXX to MHH needs until Dec. 2016
2. Biobank Information System (BIMS) of HUB
identifying data (IDAT)
Lab system MHH
(opus::L)
Clinical systems
MHH (SAP, SubSystems)
Study- / research
systems
Pseudonymization
(ZIMt)
Master Patient Index
(MPI) / (Mainzelliste)
study data,
consent-status,
external pseudonym
(PIDe)
sample- /
analysis data
jobs, positions, IDs
cinical data
Scanner
LiquidHandlingRobot
DNA/RNA
extraction
robot
diagnoses,
basic data
Datawarehouse
(MHH/ZIMt)
clinical data,
molecular data
rack-ID, sample-ID,
sample-position, working step
BiobankInformation System
(BIMS)
sample quality data
Analysis /
Research
analysis-pseudonym (PID2)
position, IDs
pick lists / jobs
Hamilton ---80°C robot
BiobankPseudonym
(PID1)
temperature,
liquid Level, sample
content
Liquid
nitrogentanks
Important quality features for modern
biobanking
1. Sample quality (processes, infrastructure, capacity)
2. IT-data quality and security (Biobank information
management system, pseudonymisation)
3. Governance of biobank, access and owner rights of
samples and data
4. Project management
5. Certification of biobank processes
6. Education and training
Often only possible in large central
biobanks
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 information
management system, pseudonymisation)
3. Governance of biobank, access and owner rights of samples
and data
4. Project management
5. Certification of biobank processes
6. Education and training
Often only possible in large central
biobanks
4. Project management
•
Biomaterials and volumes (serum, plasma, DNA, tissue,
urine, …)
•
SOPs (pre-analytics, transport, storage)
•
Informed consent (Broad, project specific)
•
IT management (sample registration
tool, MySamples, CentraXX)
•
Publication of sample collections
(BBMRI catalogue, Deutsches
Biobankregister, MHH HUB website)
•
Import of „old“ sample data to
MySamples or CentraXX, transport
of „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 information
management system, pseudonymisation)
3. Governance of biobank, access and owner rights of samples
and data
4. Project management
5. Certification of biobank processes
6. Education and training
Often only possible in large central
biobanks
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 information
management system, pseudonymisation)
3. Governance of biobank, access and owner rights of samples
and data
4. Project management
5. Certification of biobank processes
6. Education and training
Often only possible in large central
biobanks
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
Thank you very much for your attention
HUB Team
Norman Klopp, Markus Kersting
Inga Bernemann, Jana Prokein
Dirk Drobek, Karin Heine
Sisko Bauer, Mercedes Clavero
Bettina Wilhelm, Manfred Mertin
Thomas Illig
Not presented: Christina Hartmann, Urbana
Perez-Martin, Kordula Brückmann
DZL samples and projects in HUB
• 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
Sample quality in HUB
• Excellent storage conditions for millions of
samples
• 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 pre
analytics, storage and retrieval
[Coriell Institute, New Jersey]