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.