Immunoassays To Maximize Productivity In Bioprocess Development

The highly competitive market for biotherapeutics now includes many companies that are developing therapies, often for similar targets and clinical indications. This puts great pressure on companies to maintain quality, reduce time to market, and maintain cost effectiveness in the process development of antibody therapeutics.  

High productivity demands efficient bioanalytical procedures to measure, for example, product titer and process impurities, but commonly used methods, such as enzyme-linked immunosorbent assay (ELISA) or highperformance liquid chromatography, can create bottlenecks in critical workflows.

Immunoassays used to monitor bioprocess development should ideally have a number of qualities to maximize efficiency:

• High quality data quickly delivered to support confident data-driven decision making
• Rapid assay development • High analytical performance that is consistent between process stages
• Broad dynamic range and high matrix tolerance to cope with a diversity of samples, from expression to production
• Minimal demand on resources (hands-on-time and reagent consumption)
• High throughput when it counts e.g. in cell-line development and clonal selection
• Robustness for ready validation to meet regulatory demands

Here we illustrate how Gyrolab immunoassays meet the critical requirements for immunoassays used in process development of an IgG therapeutic antibody, from initial cell culture to final purified product.