Viral vector production in the integrity® iCELLis® single-use fixed-bed bioreactor, from bench-scale to industrial scale

Introduction Wild-type or recombinant viruses used as vaccines and human gene therapy vectors are an important development tool in modern medicine. Some have demonstrated high potential such as lentivirus, paramyxovirus and adeno-associated-virus (AAV). These vectors are produced in adherent and suspension cell cultures (e.g. HEK293T, A549, VERO, PER.C6, Sf9) using either transient transfection (e.g PEI, calcium phosphate precipitation) or infection (e.g. modified or recombinant viruses) strategies. Most of these processes are currently achieved in static mode on 2-D systems (Roller Bottles, Cell Factories, etc.) or on suspended microcarriers (porous or non-porous). However, these two systems are timeconsuming (large numbers of manipulation, preparation of equipment, etc.) and hardly scalable. In regards to process simplification and traceability, Integrity iCELLis bioreactors offer a new solution for scalability and monitoring of adherent cell cultures.