Manufacturing and Bioprocessing
2019 PharmSci 360
In an industry-academia collaboration, we have developed REPRESENTATIVE Downscale Models for Freeze and Thaw Processes of Biologics Drug Substance (BDS) in bottles based on CFD simulations. Their validity was tested with various therapeutic proteins in order to be able to include them as a standard element in the development of freezing and thawing processes of BDS. The present studies confirm that very similar freeze concentration distributions are achieved at scale and downscale. Ongoing investigations are seeking to reduce the current downscale model volume from 100 ml to 10 ml or less. Also thawing processes and differentiation between good and bad processing seem to be predictable using these novel downscale models.