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 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