Bioreactor Product Aggregation Assessment by the A2P2 System
Before protein aggregation assessment of any cell culture sample, an
analyst must perform affinity purification prior to injection into a
size exclusion (SEC) chromatography column. Matrix removal and protein
enrichment are essential before sample preparation and PQ assays.
Compared to the Tecan-Atoll process, the A2P2 system significantly
improves efficiency, reducing sample turnaround time by 30%-64%,
saving staff hands-on time by up to 92%, and increasing sample
processing capacity by 90%-154%. Figure 8a depicts how the
autosampler needle takes either manually collected or online samples
from the vial or FTV and directs them through the affinity capture
column. The column captures the protein of interest, while the sample
matrix is flushed to waste through the FTV. The eluted protein of
interest accumulates in the FTV as the affinity-purified sample, which
can subsequently be injected into the analytical sizing column for
aggregation level quantification by a UV detector. Samples that are free
from cell culture matrix or have undergone affinity purification in
downstream processes require no further affinity capture/cleanup.
Analysts can directly inject these samples into the analytical sizing
column, and a UV detector quantifies their aggregation level.