Accurate quantification of a biotherapeutic, typically an antibody, is needed from cell line development and clone selection through to bioprocess development and production. To maximize productivity and efficiency, the assay format must therefore be reliable over a broad working range.

Save analyst time

		Fewer dilutions or repeats - broad dynamic range, reduced matrix effects, requires minimal sample volumes
		Minimize sample and reagent consumption
		Fast assay turnaround - automated platform
		Multi-application platform producing high quality data

Transfer easily between labs or into regulated environments

		Template methods simplify outsourcing and assay transfer
		Gyrolab software is 21 CFR Part 11 compliant and regulatory support is available

Data examples

Measure from picogram to milligram

Results demonstrate the broad dynamic range covered by two Gyrolab Bioaffy CDs. This ensures that the immunoassay platform can be used to quantify small amounts at low concentration during early development through to high concentration IgG titers in large-scale batch manufacturing.

Scalable assay format

Product quantification, IgG, Titer, Expression, Cell line development, Clone selection

Monitor IgG production during clone selection

Results demonstrate the efficiency of using a multi-application immunoassay platform. Different cell lines can be monitored for IgG and host cell protein production using the same immunoassay platform.

Multi-application platform producing high quality, reproducible data

Impurity testing (HCP), Host cell proteins, Monitoring, Contaminants, Activity binding assay, IgG, AstraZeneca

Data courtesy of Astra Zeneca

Monitor IgG production during optimization of cell culture conditions

This work determined the effect of parameters such as temperature and media on the production of target IgG as well as HCP contaminants.

Efficient use of a multi-application platform

Product quantification (lgG titer), Expression, Cell line development, Clone selection, Monitoring, GE Healthcare, HCP

High reproducibility

Low coefficient of variation values demonstrated the high reproducibility achieved throughout the monitoring process.

Impurity testing (HCP), Host cell proteins, Production, Monitoring, Contaminants, Activity binding assay, IgG, GE Healthcare

Data courtesy of GE Healthcare

Correlate with existing assay formats

Results correlate well with existing assays. Compared to conventional formats, the Gyros immunoassay platform consumes less sample and reagent, avoids the need for significant dilution before analysis and often offers greater throughput or automation capability.