Client: Novasep
Location: Belgium (South)
Completion: 2019
Total Investment Cost: ca. 27m€

Implementation of new Green Field Viral Vector Production facility, including 2 cGMP production units. One unit is dedicated to adherence cell culture for viral vectors in moderate quantities (to treat certain rare diseases or for lower dose indications and one unit for suspension cell culture with bioreactors up to 2000L to produce larger quantities.

Commissioning and Qualification (including project qualification strategy, URS, Risk Analysis, FAT, SAT, IOPQ, CSV).

Utilities/ Facilities: HVAC, Purified Water production and distribution, Clean gasses (Compressed Air, CO2, O2, N2) production and distribution

Process Equipment: Bioreactors, Clarification skids, (Ultra)filtration skids, chromato skids, buffer prep skids

Automation: AMS, EMS, Interlocking

Support Equipment: Decontamination System, Decontamination autoclave, Sterilisation autoclave, LAF cabinets, Biosafety Cabinets