1. INTRODUCTIE: PROFIEL EN FUNCTIE Biobank Infrastructure

2. Planning and realisation Bimetra biobank facility Fund of the Flemish government (FFEU) for the realisation of a biobank with cryogenic storage capacity of 25.000L 2 Total investment plan : 1.326.000,00 € (FFEU) - Jan 2014: initial building plan - March 2014: refining, detailing and finalising the building plans Fase 1: 832.543,69 € - Apr to Nov 2014: Renovation basement (matching funds UZG) and realisation of the building plans - Nov 2014: Move into the new biobank facility - Quality audit (CMI) : Nov 2014 Fase 2: 493.456,31 € - Implementation service level conditions - Implementation of quality control tests - Purchase file digital pathology scanning device - Sample collection: cradle-to- grave analyse= mutual effort Temporary facility -1P8 (end of 2012 until dec 2014)

3. Location facility 3 Bimetra biobank DWG R, -1

4. How to reach the biobank? DWG R: in renovation Temporary access road: Through building B3 Go to -1 (basement) Follow the signs: go in the direction of “dwarsgebouw” Separate temporary access road to the biobank Through the underground network of tunnels Tunnel connecting K1-K2-K3 From K3 to building B3 Follow to the end Separate temporary access road to the biobank 4

5. Virtual tour: general building plan 5 Invoegen algemeen grondplan met zonering uit iDOCs High quality biobank facility: -Entrance: sas -Sample reception area -Laboratory for sample preparation -Cryogenic facility: -45 ULT (-80°C) freezers -6 storage LN 2 -vessels

6. Access to the biobank: changing area 6 Bimetra biobank: Area with limited/ controlled access (badge reader) Visitors: login register Changing area

7. Changing area: keeping it clean 7 Changing area: Put on shoe covers (anti-slip) Remove “outer wear” (jackets, scarfs…) and put on “inner wear” overcoat Hand wash facility

8. Overview: entrance – sample reception area - cryofacility 8

9. Sample reception area 9

10. Right zone: “dirty area” Sample delivery Transport boxes Flow: Unpacking/uncasing of samples Intake in datamanagement system Labelling according to following procedures 10

11. Sample reception area Go to the “clean area”, sorted according to further procedures 11 Preparation of samples Color coded Temporary label Direct freezing On dry ice Cryovial label

12. Laboratory: sample preparation and QC 12 Laboratory overview

13. Laboratory: sample preparation and QC 13 Zone 1: sample prep Aliquoting of liquid samples Serum preparation Cell culture …

14. Laboratory: sample preparation and QC 14 Zone 2: sample prep QC DNA- and RNA extractions QC on samples …

15. Laboratory: sample preparation and QC 15 Zone 3: sample processing FFPE slide preparation Cryoslide preparation future: digital scanning device for slides …

16. Cryogenic facility: area 1 (ULTs) 16 Facility for 45 ULT (-80°C) freezers Existing freezers from P8 < New Brunswick (mixture of models) New freezers for short/temporary storage of samples < framework agreement with TCPS (Panasonic MDF-U700VX-PE) New freezers for longterm sample storage < framework agreement with Thermo Fisher Scientific (88600V and 820CV models, with storage racks and boxes)

17. Cryogenic facility: area 1 (ULTs) 17 Storage racks: High sample storage efficiëncy 0,5ml eps, 2 ml cryovials, 4 ml cryovials PAX, EDTA, 15ml tubes Ease in traceability of samples < linked in data management system SLims

18. Cryogenic facility: area 1 (ULTs) 18 High quality facility “tailormade” airconditioning according to capacity Maintenance regime: preventive Monthly maintenance of freezers (registration logbooks): Ice removal and drying Checking and cleaning of valves, closures and rubbers Checking and cleaning of filters Yearly planned preventive maintenance by the company

19. Cryogenic facility: area 1 (ULTs) 19 Power supply: separate circuits for each freezers and emergency power Double monitoring control: Device generated alarms: Through potential-free contact < facility management system Internal device monitoring system (Thermo Fisher Scientific): short term registration of temperature and events/alarms < USB port Device generated alarm if case of too high surrounding temperature

20. Cryogenic facility: area 1 (ULTs) 20 Double monitoring control: Device independent alarms: Aeroscout Independent temperature sensor Aeroscout in each ULT < Wifi-network < continuous temperature monitoring and –registration Independent temperature sensors Aeroscout in the facility < Wifi-network < continuous environment temperature monitoring and –registration

21. Cryogenic facility: area 2 (LN 2 ) 21 LN 2 facility: adapted to safety requirement LN 2 specific flooring LN 2 lines for automatic filling Oxygen detection (visual/auditive alarms) Emergency masks for evacuations Personal safety means

22. Cryogenic facility: area 2 (LN 2 ) 22 CBS Isothermal freezers (patented new technology) High storage capacity (± 35.000 2 ml cryovials/vessel) Automatic filling with build-in monitoring device Small access port Sample tower carrousel Double monitoring

23. INTRODUCTIE: PROFIEL EN FUNCTIE Biobank:Qualitymanagementsystem

24. Quality management system 24 Quality norm: CMI-CRC guidelines (published oct 2010) Quality audit Nov 2014: highly positive Implemented systems: IDOCs: ZH wide document management system IML: ZH wide registration system for quality deviations or abnormalities and audit reports Future objective: ISO-norm for biobanks (involved in ISO working group) ISO15189 & ISO17025: test labs NOT biobanks

25. 25 Quality system Sample and data management through Slims Use of minimal datasets (MDS) and international SPREC coding for sample history Software validation Automatic data retrieval by coupling of other datasystems Use of ZH wide system iDOCS and IML Procedure/ process validations Device validations Quality control of samples Full sample traceability and audit trail Access control (badge) On site back-up freezers, emergency procedures and contracts Double monitoring of all storage devices Involved with local policy HBM < autonomy General flows for sample access Harmonised MTAs and cost models Following directives and decrees regarding us of HBM

26. In conclusion: Cryogenic biobank facility is fully operational High quality standards

27. 27 Biobank: waarom samenwerking en kwaliteitssystemen? Biobanking “at its best”: High quality repositories Annotated samples Collaborative model Harmonized QA/QC Economy of scale Harmonized guidelines/rules Drivers for translational research Bewustwording ikv publicaties: Harmonisering kwaliteitssystemen Harmonisering opslagmethodes Belang ICF Belang sample history: invoering minimale gegevens behorend bij samples: vb SPREC codering

28. Kwaliteitsnormen 28 Vlaamse biobank initiatief CMI-CRC guidelines (gepubliceerd okt 2010) Gebaseerd op ISO 9001 Best Practices for Repositories – Collection, storage, retrieval and distribution of biological materials for Research – ISBER 2012 Common minimum technical standards and protocols for biological resource centres dedicated to cancer research – WHO IARC Working group reports vol. 2 OECD Best Practice Guidelines for biological resource centers – 2007 Toekomst: ISO voor biobanken (betrokken in werkgroep) ISO15189 & ISO17025: test labs NOT biobanks