Tania Pereira Chilima, CTO at Univercells Technologies examines the challenges gene therapies face during production and how integrated and continuous processing can help.
Over the last decade, the industry has advanced monoclonal antibody (mAb) processes, working toward continuous processing to reduce manufacturing footprint and increase the overall productivity. Initially this work started with increasing upstream productivity before moving into overcoming midstream and downstream processing challenges. These unit operations would eventually be combined via significant technology innovations.
With so much progress made in mAb production, the industry is now seeking answers for newer modalities like gene therapies (GTs). Though demand for gene therapies is skyrocketing, these products are dependent on the availability of viral vectors for commercialisation. Present technologies used for mAbs deliver low titers and limited performance, constraining developers to scaling-out their process rather than scaling-up. The need to run parallel operations increase the overall volume and footprint needed to achieve commercial production scales.