Jak biotech park funguje

Přístrojové vybavení

– 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)