Planning for Production Scale
The development of an industrial process should begin right at the start – when the product is still at the preclinical stage.
Daniel Maier |
The design and development of the optimal production process is a big challenge – and it’s rare that upscaling runs smoothly. The growing demand of monoclonal antibodies (mAbs) requires efforts to increase production capacities and product titers. Experience shows that an ideal up-scaling process tends to rely on the field of hydrodynamics and process engineering; numerous indicators and values are needed to develop the right strategy. Many parameters, such as mixing time and the volumetric mass transfer coefficient (kLa), however, cannot be transferred in a linear manner, so successful up-scaling always involves compromises.
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