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)