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– Unikátní izolátorové pracoviště – vlastní proprietární vývoj
– Alogeneic robotic cell line
– Nano production cGMP line
- Vital and non-vital particle monitoring
- In-house microbial control (BactAlert)
- Qualitative and quantitative QC methods — flow cytometry, PCR, ELISA, cell counters, microscopes (ordinary, FLD)
- Full scale QA / QC management of whole manufacturing process, 4x QP
- Unique SOPs for QA / QC of each manufacturing step (starting from cell acquisition, ending at product delivery)
- Bar codes and Labeling, traceability
- Ensuring chain of identity, ensuring CE compliance for all materials and consumables
- In-house donor / patient registry (EU / CZ legal compliance)
- GLP in Laboratory for Quality Control (sterility testing)
