Navigation auf uzh.ch
Navigation auf uzh.ch
The Center for Therapy Development/GMP operates a Cell- and Tissue Biobank (CTBB) service unit (Regulation and MTAs (PDF, 196 KB)). The biobank's focus lies on handling cryogenic sample material from two differently regulated areas:
| Pre-clinical research | Clinical research |
|---|---|
| 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). Currently, CTBB is handling cryo-material for various studies from three different research groups. | 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). Currently we are handling cryo-material for five clincial studies in phase I/II. |
Site-specific labelled cryo-tubes are provided by CTBB. 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. If you are planing to store cryogenic sample material within CTBB, please use cryo-tube and order-formats as indicated:
| 1.4 ml volume (Order) | 2.0 ml volume (Order) | 3.0 ml volume (Order) |
|---|---|---|
The qualified infrastructure and validated processes enable the documented controlled rate freezing (A) and storage (B) of human tissues and liquids (e.g. plasma, serum, blood, cells, biopsies, etc.) without interrupting the cooling chain from the timepoint of sample freezing until retrieval. Samples with a BSL ≥3 or containing radioactive material may not be processed or stored at any time.
|
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. |
|
|
|
|
|
CTBB provides electronical documentation for the cryopreservation (C) and storing process (D). CTBB provides a database system for external registration of samples labelled with barcodes (see also CRYO-TUBES). After sample registration (Download Importfile (XLSX, 356 KB)) the samples are delivered to CTBB, cryopreserved and stored. 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. |
|
|
|
