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The iPSCore operates a biobank (iPSCore-BB) unit (Regulation and MTAs (PDF, 196 KB)). The biobank's focus lies on handling iPSC-based cryogenic material from two differently regulated areas:
| Pre-clinical research | Clinical research |
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| For pre-clinical prospective studies, CTBB provides researchers guidance regarding cryo-preservation, comprising registration, sample handling, storage and distribution according to the Human Research Act (HRC). | CTBB is handling all relevant steps under an EU-GMP compliant QM system meeting current GMP requirements and the Therapeutic Products Act (TPA). This enables the asservation of cryogenic material for therapeutic interventions (Swiss Medic approval: 1009863 and 507397). |
Site-specific pre-labelled cryo-tubes are used by iPSCore-BB. Tubes are assigend with unique number group IDs, indicated by durable ECC 200 datamatrix- and 2/5 interleave linear barcode and human readable ID on each tube. The IDs are long-lasting laser-printed directly onto the surface of the tube with a strong resistance to temperature, chemical and mechanical damage:
| 1.4 ml volume (Order) | 2.0 ml volume (Order) | 3.0 ml volume (Order) |
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The qualified infrastructure and validated processes enable the documented controlled rate freezing (A) and storage (B) of iPSCs without interrupting the cooling chain from the timepoint of material freezing until retrieval.
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A) Temperature sensor controlled rate freezing: for documented sample freezing according defined and reproducible freezing gradients down to -150°C. |
B) Individual and automated sample registration and handling: guaranteeing an uninterrupted cooling chain below -150°C (gasphase of N2) from sample registration and storage until sample retrieval. |
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The iPSCore-BB established electronical documentation for the cryopreservation (C) and storing process (D). Cryogenic stored iPSCs are registered in a qualified and validated database system. After request, the database can be accessed to query samples and request sample retrievals.
| C) Documentation controlled rate freezing: Cryopreservation of each individual sample is documented. | D) Sample archive: The inventory of all stored samples can be accessed client-specific via a web-based application. |
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| iPSCore-biobank (iPSCore-BB) | Moussonstrasse 13 | Phone: +41 (0)44 634 5674 |
| Institute for Regenerative Medicine (IREM) | 8044 Zurich, Switzerland | Fax: +41 (0)44 634 5608 |
