Scientific Concept of the National Cohort (status ... - Nationale Kohorte

121
A.3 Study design
� manual working archive at the hmGu in Munich/Neuherberg (vapor phase of liquid
nitrogen, –180°C)
� manual local back-up archives at a defined number of centers (vapor phase of liquid
nitrogen, –180°C)
Of the collected plasma and urine samples, two thirds of the aliquots will be sent to the central
biobank at the HMGU. For cost reasons only one sixth of the aliquots will be imported
primarily into the automated biorepository (5x serum, 8x plasma, 1x erythrocytes, and 2x
urine). The automated working archive will be fed from the manual working archive reservoir
as soon as materials have proved to be ”very important materials” (VIM). Thus, over
time the automated working archive will be enriched with VIM.
The other third of the plasma and urine aliquots will be stored in local back-up archives.
Blood for later DNA extraction, RNA-stabilized blood, saliva samples, stool samples, and
swabs will be stored centrally in manual –80°C freezers. Similarly, also large-volume urine
aliquots and urine sediments will be stored in –80°C freezers.
Construction of a new building for central storage at HMGU
Centralized storage at HMGU of biomaterials obtained from all cohort participants throughout
Germany requires a new building that accommodates
� The automated biorepository.
� The liquid nitrogen tanks for the additional blood and urine samples as well as the viable
cell storage.
� The manual –80°C freezers for the additional materials (blood for later DNA extraction,
RNA stabilized blood, stool, saliva, and nasal swabs).
� The laboratory required for the central processing of samples and for quality control.
One laboratory task is the separation and cryopreservation of viable cells from BD
CPT tubes sent by the study centers; Furthermore, on-demand extraction of DNA and
RNA (with separate funding) will be offered.
� The space required for the central biosample data management.
� The offices of personnel running the store, the central laboratory, and the management
of laboratory data.
The planning for the building has started and it will be finished in 2012. The automated archive
(repository) will be installed in the middle of 2013. Interim storage will be performed in
the vapor phase of liquid nitrogen tanks in an existing vacant building of HMGU.
Automated biorepository at HMGU (–80°C)
Storage and retrieval from the automated biorepository represents an indispensable prerequisite
not only for storing and tracking large numbers of aliquots, but also, and even more
so, for retrieving single aliquots. Manual access to single aliquots (as opposed to complete
racks) would not only require an immense time expenditure but also create difficulties in
controlling exposure to higher temperature of both the selected and adjacent aliquots and,
hence, in the long run would result in the progressive deterioration of the store's contents
and value.
The HMGU Biobanking Planning Group, along with an international “Advisory Committee'”
experienced in biobanking (from UK and Sweden), have already visited all major suppliers
of –80°C automated biorepositories [in alphabetical order: Fraunhofer (Saarland), Hamilton
(Switzerland), Liconic (Liechtenstein), REMP-Nexus (Switzerland), TAP (UK), and the two
A.3