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Beneficial application of protein-free medium in industrial processes with mammalian cell cultures producing biopharmaceuticals

Deliverables

A safe source for the cell material is a critical requirement for the production of biopharmaceuticals with mammalian cell lines. This result provides a reliable strategy for cryopreservation of producer cell lines using defined cryopreservation conditions that are not dependent on any components of animal or human origin. This enables the establishment of cell banks of very high quality and bio-safety standards as sources of cell material for the manufacturing of biopharmaceuticals with mammalian cell cultures. This result consists of an optimized method for cryopreservation and revitalization of mammalian cell lines using protein-free cryopreservation media that are free of any components of animal or human origin. The method comprises optimized protocols for 1) the transfer of the cells to the cryopreservation media and freezing of the cells and 2) thawing of the cells and their transfer to chemically defined culture media. During the project the method has proven its applicability to various producer cell lines (BHK, CHO, MDCK). The method provides a reliable strategy for the cryopreservation of mammalian cell lines using chemically defined cryopreservation media and thus enables the establishment of safe sources of cell material for the production of biopharmaceuticals with mammalian cell cultures.
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.