Removal of protein aggregates from biologic drug products is critical due to their potential to increase antigenic response and the associated negative impact on the patients. Aggregates may be formed during upstream or downstream operations when suboptimal purification parameters are selected.
Once formed, aggregate removal and/or reduction becomes challenging for the downstream purification process development team. Chromatography is the most traditional purification technology used for aggregate removal; however, chromatography methods could actually increase aggregate formation as the product is exposed to harsh conditions such as low pH or high salt. Column chromatography is also time consuming, requiring several buffers, method development, and costly technology such as purification skids and columns.
SystImmune and Sartorius are exploring an alternate technique exploiting the Virosart® Max filter. The Virosart® Max is an optimized triple-layer polyamide pre-filter specifically designed to remove aggregates and protect the expensive downstream virus removal filter. The Virosart® Max will be operated in a simple flow through mode to demonstrate aggregate reduction in a bi-specific antibody model.
This robust filter-based aggregate removal strategy would offer simple buffer preparation, minimal process development, and the option to replace costly chromatographic skids with inexpensive pumping equipment.
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