Process development
Upstream
Screening of production cell clones
High-density cell banking
Process establishment of fed-batch processes
Screening and selection of media and feeds
Media and feeding strategy optimization
Process parameters optimization
Quality attribute modulation
Process scale-up
Reliable technology transfer, verification, and optimization
Supply of material for every development and production stage Establishment and qualification of down-scale models to support process characterization and process validation
Downstream
Development of purification processes including chromatography, tangential flow filtration (TFF), virus filtration steps
Optimization of individual purification steps
Development of virus removal strategy and conditions
Downstream process scale-up
Reliable technology transfer, verification and optimization
Process validation activities including scale-down model qualification, resin lifespan study, process characterization
Formulation
Design and execution of formulation development strategies for complex biopharmaceutical formulations
Conducting of accelerated and stress studies to identify suitable formulations under process related stress and to understand the physical and chemical degradation pathway
Identification of excipients and optimal conditions to maintain protein properties and long-term product stability
Comprehensive analytical physicochemical characterization of formulations
