Developing A Sterilizing Grade Filter For High Concentration Biologics

The landscape of drug formulations is evolving, with a growing preference for subcutaneous administration over traditional intravenous infusion.

Developing and manufacturing subcutaneous biologics presents challenges, especially in the sterilizing or bioburden reduction filtration for drug substances that are highly concentrated (over 100 g/L) and viscous (10-30 cP). Two major issues are the need for larger filters due to the high fouling potential of these feeds and the relative product scarcity during process development. These can lead to the loss of valuable drug substance in the hold-up volumes of the filtration assembly and system as well as a limited scope for meaningful filter benchmarking studies.

This presentation outlines an approach to developing a new sterilizing-grade filter specifically designed for high-concentration biologics that enabled extensive filterability trials to be conducted without needing to generate a large quantity of the expensive product.