Process Development: Rapid Identification of Critical Process Variables
Process development is a key element in the creation of improved, more rapid and lower-cost methods for producing target products. Through feeding strategies, pH value optimization and the integration of various cultivation phases in a single process, DASGIP users can optimize growth, stability and productivity levels.
With up to 16 highly instrumented vessels, DASGIP systems allow users to rapidly establish reproducible and therefore comparable results on the basis of critical parameters. The wealth of information, parallel design and access to data mining tools permits the systematic analysis and comparison of process data. Process validation is thus having a greater impact on the subsequent approval process for the products under development. As part of its "Quality by Design" program for instance, the FDA promotes continuous improvements in development and production processes, thus shifting the focus further away from the analysis of already-manufactured foodstuffs and pharmaceuticals, to the process itself. By introducing process analysis technologies (PAT) in the development phase, the initial aim is to acquire a better understanding of the process, which ultimately leads to optimized production processes.
Please find information on the use of DASGIP Systems in process development e.g. for the process automation, production of recombinant proteins, antibody production in mammalian cell cultures or development of biofuels here.