Improve Product Quality As Early As Clone Selection

Product aggregation is a major stability, efficacy, and safety concern in the manufacturing of antibody therapeutics, particularly for highly engineered molecules such as bispecifics. As therapeutic molecules become more complex and pressure to shorten development timelines increases, the ability to screen and select production cell lines for critical quality attributes like aggregation as early as possible has become a critical challenge in bioprocess development.

The Opto™ Assure assay series for CHO cell line development is an enhancement to the Opto™ CLD workflow on the Beacon® system that provides product quality information at the earliest stages of cell line development. Here we introduce the Opto™ Assure Aggregation assay, the first in the series, which enables detection of product aggregates within days of single cell cloning and show how this assay allows you to:

• Screen for both yield and product quality at the single-cell cloning stage
• Identify CHO cell lines with favorable manufacturability profiles earlier in cell line development
• Reduce costs, shorten timelines, and improve probability of success by selecting fewer, better clones for scale-up