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With the development and manufacture of subcutaneous biologics come challenges in the sterilizing or bioburden reduction filtration of drug substance that is both highly concentrated (100 g/L) and viscous (10-30 cP). Two significant problems are:
1. The use of larger filters as a consequence of the high fouling properties of the feeds. This results in the loss of high value drug substance in hold-up volumes in both the filtration assembly and system.
2. The relative scarcity of product during process development. This results in limited opportunities for meaningful filter benchmarking studies and can lead to sub-optimal filter selection.
In this presentation we share the approach we took to develop a new sterilizing grade filter for high concentration biologics, which allowed us to undertake extensive filterability trials without the need to generate a high quantity of expensive product.