Design and Scale-Up by Laboratory Experiments and Process Simulation
18.10.2016 - 20.10.2016, Clausthal-Zellerfeld
For synthetic APIs, increasing attempts to move from traditional batch to continuous manufacturing are ongoing. Advantages are in particular higher product safety by enhanced process robustness, smaller foot print of the plants, lower cleaning costs and down-times due to dedicated modular and flexible plants.
For the production of biopharmaceuticals, e.g. monoclonal antibodies, fermentation is already more often used in a continuous perfusion mode than is known to the public. Therefore, it is only consistent to apply continuous process concepts also for downstream processing operations. In manufacturing of biomolecules these concepts have so far only been applied for high-volume bulk or fine chemicals. However, with the upcoming cost issues in the manufacturing of biotherapeutics by low cost biogeneric manufacturers and stratified medicine scenarios, first approaches to industrialize continuous manufacturing for biologics like amino acids, peptides, proteins and monoclonal antibodies and fragments, are under investigation
The course will describe the design and scheduling of unit operations in continuous manufacturing processes in contrast to classical batch operations and aims at providing viable decision criteria.