This result represents a method for the design and optimization of chemically defined cell culture media used for the production of biopharmaceuticals with mammalian cell cultures. The design of chemically defined cell culture media that are free of any components of animal or human origin is an important prerequisite for the establishment of processes of a high bio-safety standard for the manufacturing of biopharmaceuticals. The described method provides a reliable strategy for the design and optimization of these cell culture media. During the project it proved to be applicable to various cell lines and processes.
This result comprises an improved strategy for the design of chemically defined cell culture media that are free of any components of animal or human origin. It considers the specific needs of the producer cell line as well as those of the given process.
The first step of the strategy is the adaptation of the producer cell line to one of the protein-free SMIF media. The media of the SMIF medium line have been proven to be applicable for many cell lines of industrial relevance such as CHO, BHK, MDCK and others. After the successful adaptation the producer cell line will grow under protein-free cultivation conditions.
During the adaptation phase, cultivation parameters that are critical for the given process (for example, productivity or product integrity), must be monitored. On the basis of these data the basal protein-free medium is then supplemented with chemically defined components to improve the performance of the culture with respect to the process requirements. The new medium formulation is then tested under process conditions with the critical parameters monitored again. This procedure is an iterative process and will be repeatedly performed until the critical parameters reach the values required for the given process.
In the end, the application of this strategy results in a formulation for a chemically defined medium that is free of any components of animal or human origin while being optimized to meet the specific needs of the given producer cell line and manufacturing process.