cGMP Manufacturing
and Quality Control

Professional cGMP manufacturing services covering all well known production approaches and QC methods for cell and gene therapy products and viral vectors. 

We can offer

  • We can offer all services covering autologous or allogenic cell & gene therapy products
    as well as viral vectors, all within dedicated or shared manufacturing suites.

  • See our facilities

  • Manufacturing process from various starting materials (e.g. apheresis products, whole blood, tumor tissue etc.)
  • Manufacturing of each batch is managed via internal laboratory software system LaSSo™
  • Automated or manual fill and finish services
  • Customized cryopreservation of DS and final DP as well as samples for further QC
  • Preparation and characterization of cell banks from MCB to WCB
  • Labeling and re-labeling services
  • QC testing based on variety of cell based and molecular methods
  • Microbiology testing
  • Rapid sterility testing methods
  • Characterization assays and release testing
  • Backup for materials and outsourced tests
  • All necessary backup systems in place – all for GMP facility, including independent storage
  • Stability studies
  • Testing of raw materials
  • Ability to accommodate Person-in-Plant

Our Services