Abstract
Background A steady increase of product titers and the corresponding change in impurity composition represent a challenge for development and optimization of antibody production processes [1,2]. Concentration and composition of impurities like host cell proteins (HCP) are critical for efficient process development. These impurities show significant variations, which primarily depend on cell culture conditions. They have a strong influence on the downstream processing (DSP) and costs [2]. It is already shown that not optimized changes of parameters in USP can change the impurity profile by a factor of 7 [3]. The resulting “bottleneck” in DSP requires new optimization, technology and development approaches. These include the optimization and adaptation of existing unit operations respective to the new separation task, the assessment of alternative separation technologies and the search for new methods in process development [2].
Highlights
A steady increase of product titers and the corresponding change in impurity composition represent a challenge for development and optimization of antibody production processes [1,2]
Material and Methods By changing cell culture media compositions according to DoE screening designs, influences of media components on the host cell proteins (HCP) concentration and composition are identified
ATPE can be used as cell harvest method
Summary
A steady increase of product titers and the corresponding change in impurity composition represent a challenge for development and optimization of antibody production processes [1,2]. Concentration and composition of impurities like host cell proteins (HCP) are critical for efficient process development. These impurities show significant variations, which primarily depend on cell culture conditions. They have a strong influence on the downstream processing (DSP) and costs [2]. The resulting “bottleneck” in DSP requires new optimization, technology and development approaches. These include the optimization and adaptation of existing unit operations respective to the new separation task, the assessment of alternative separation technologies and the search for new methods in process development [2]
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