An ongoing demand for novel biopharmaceuticals, the increasing complexity of the production of biologics and a need for larger production capacity are all factors that have applied pressure to the cell culture process and its associated technologies. Cell culturing and its resources have evolved and scientists now work across numerous transformation established cell lines, primary cells and uniquely demanding cell types (e.g. stem cells) which is creating new challenges for bench and commercial scale processes. As such, the application of validated cell culture systems is essential for the safe, efficient production of monoclonal antibodies, therapeutic proteins, drugs and vaccines.
While much of the initial basic cell culture science takes place in the research lab, this work often needs to be scaled up in order to accommodate commercial requirements including process optimization and validation. Scaling up cell culture processes can prove difficult for many organizations as there are numerous regulatory and technological considerations, GMP compliance and the ever-present need to guard and prevent batch variability and contamination. A significant amount of time and effort goes into early stage research and it is therefore imperative that the transition from bench to industrial scale be an obvious and natural extension of the bench top cultivation conditions.