Generating Higher Quality Data
Faster product development is not the only reason why laboratories switch from conventional ELISAs to an automated assay platform. They do so because they also acquire higher quality data that enables data-driven decision-making.
A robust immunoassay platform with automated workflows avoids handling errors associated with manual methodologies. The results it yields will thus be more precise and more reproducible.
In addition, a platform with broad dynamic range, such as Gyrolab systems, can lower the minimum required dilution (MRD), further reducing experimental variability caused by dilution error. Note also that a broad dynamic range can be especially valuable in applications requiring the detection of very low concentrations of analyte.
Case Study: More Precise Quantification of Bioprocess Impurities at Pfizer
Host-cell proteins (HCPs) are a major group of impurities for biologic drugs produced in cell culture expression systems. Accurate quantification of HCPs is critical, but also challenging. Today, broad-spectrum ELISAs are commonly used for this task.
In their search for a more precise assay technology, the Analytical Research and Development team in the BioTherapeutics Pharmaceutical Sciences group at Pfizer compared their standard ELISA to several automated immunoassay platforms, including Gyrolab xP. After having evaluated and compared precision, accuracy, linearity and dynamic range, the team concluded that the Gyrolab platform stood out due to its performance characteristics (including precision) and efficiency. It yielded superior quantitative results compared to ELISA with very high (0.96) correlation.
Table 1 demonstrates the increase in data quality obtained by Gyrolab xP compared with standard ELISA. Note also the much faster time-to-result (1.5 hrs vs. 8 to 24 hrs) that the automated workflow offers.