Manufacturing Recombinant Protein Therapeutics under Cost Constraints
Therapeutic proteins such as monoclonal antibodies and fusion proteins represent one of the fastest growing segments in the drug pipeline, which puts pressure on economical manufacturing. Therefore current manufacturing trends are focused on limiting effort, costs and risk. Typical approaches are for example applying disposables, reducing the number of steps in platform processes, using modular concepts and replacing costly affinity resins. Several case studies highlight successful process design, optimization strategies, and critical manufacturing parameters.