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1
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- Diane Johnson, Craig Hines, and John Williams
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2
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- Drivers
- Genomic revolution
- Treating Human Disease – Research with Human Samples Is Critical
- Personalized medicine
- Increasing Importance of all new “-omics” technologies:
Pharmacogenomics and Translational Biomarkers
- Philosophically
- Practically
- High Risk and Cost External Sample Storage
- New Drug Productivity - seamless access between the clinical
environment and the discovery researcher
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3
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- Why store samples?
- Clinical trials are expensive
- Samples are collected for primary protocol end-points
- Considerable sample “wasted” – maximize value of clinical data and
sample use
- Latent value in samples – both near and long-term
- Biomarkers: Indicators of effects on
- Target
- Mechanism
- Outcomes
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4
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- Leverage Material Management CoE Experience
- Centralized processing
- Single point of contact for Receiving
- Maximize capital equipment utilization
- Optimal personnel deployment
- Reliable distribution – Fed Ex
- Biomaterial Experiments are planned in advance – modulates sample
retrieval access rates
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5
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- Modular –80ºC units commercially available
- Capacity limited
- Sample retrieval/consolidation not at –80ºC
- Physically scalable but not economically sound
- Single Automated Store
- Designed capacity
- Samples at –80ºC+/- 5ºC for all processes
- Integrates –20ºC storage for DNA
- Economically sound investment
- Appropriate challenge - fun
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6
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- REMP combination -20°/-80°C store
- Storage of biological samples
- -20°C – DNA
- -80°C – blood, serum, plasma,
urine, etc.
- Single store – reduced ECU costs
- Challenges
- Temperature flux during tube picking
- Condensation
- Access rates
- Migration/transition from legacy systems to REMP Store
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7
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- DNA –20ºC, multiple use – multiple freeze/thaws
- Two modes
- Retrieve complete stock tube racks – produce required aliquot in same
format
- Cherry-pick selected DNA samples from multiple racks
- Return stock tubes to original storage rack/location
- Prevents storage rack fragmentation
- Eliminates rack consolidation
- Adds an acceptable overhead in processing time
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8
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- Conservative approach – long-term storage –80ºC
- Single use tubes
- All samples at –80ºC for all processes
- Two modes
- Retrieve complete stock tube racks – deliver
- Cherry-pick selected Biofluid samples in desired format
- Novel algorithm/storage to maintain access rates
- Static rack footprint – decreased density over time
- Rack consolidation is an option – internal order
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9
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- Global BioBank Automated Storage System (GBBASS) project initiated in
September 2003
- Contract signed June 2004
- Partial FAT – Oberdiessbach April 2005
- Assembled on site – SAT December 19/20, 2005
- Building – December 2004 –July 2005
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10
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- Custom Freezers and Cooling
- LES (Luwa Environmental
Specialties)
- Standard REMP Store with modified robot grippers
- New software and algorithms for –80ºC sample retrieval
- REMP designed freezer door mechanisms
- “Proof-of-Concept FAT
- Identified successful elements
- Identified specific changes required
- Reduced project timeline
- Reduced costs for shipping and assembly
- Well worth the risk
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11
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12
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- Semi-automated
- Tecan workstations – custom applications
- Electronic files loaded directly to Oracle Database
- Global Biomaterial Management – (GBM)
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13
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14
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15
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16
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17
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- Replicates prepared during preceding year
- DNA Stored at -20°C
- Transferred via REMP insulated carts
- No freezer to IOB condensation issues anticipated
- Biofluids stored at–80°C
- Transferred to REMP store on dry ice
- Load single TRackP at a time to IOB
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18
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- GBBASS application
- Integrates Daedalus BTMTM , GBM, and Biofluids
BioBank
- Associates orders with specific robot aisles
- Pfizer “aisle” loading for replicates
- GBBASS transfers all replicate data to REMP API
- REMP optimizes retrieval rate from –80ºC freezers using algorithm
selected replicates
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19
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- Understanding, tolerance, perseverance, clarity of purpose and humor
essential with multiple vendors interacting
- User requirements for IT demanding and frustrating
- Align Business practices with systems feasibility and practicality
- Prototype freezers require adaptability and flexibility in schedules
- Leverage common global systems
- REMP API, Pfizer GMMASS Application, Pfizer GCM Oracle, Pfizer GCM API,
VPN Access, Servers and Firewalls
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20
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- Commercial Application - Daedalus Software Inc.
- www.DaedalusSoftware.com
- Biomaterial Tracking & Management (BTMTM) System
- Core functionality used and specific components added for biofluids
- Web based ordering
- Storage locations user specified –multiple levels
- Shipping and tracking functionality added
- Full audit trail and chain-of-custody from receipt through laboratory
processing and order fulfillment.
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21
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22
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23
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24
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25
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26
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27
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28
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29
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30
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31
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32
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33
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- September – December 12, 2005
- Software installation and testing
- Robotic, shelf, and freezer alignment
- On-site “FAT” December 13-16, 2005
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34
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Notes